hMG

Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection.

To evaluate the efficacy and safety of highly purified human menotropin (HP-hMG) and recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in a population of patients predicted to be high responders. Randomized, open-label, assessor-blinded, parallel-group, noninferiority trial. Fertility centers. A total of 620 women with serum antimüllerian hormone (AMH) ≥5 ng/mL. Controlled ovarian stimulation with HP-hMG or rFSH in a GnRH antagonist assisted reproductive technology (ART) cycle. Fresh transfer of a single blastocyst was performed unless ovarian response was excessive, in which all embryos were cryopreserved. Subjects could undergo subsequent frozen blastocyst transfer within 6 months of randomization. Ongoing pregnancy rate (OPR) after fresh transfer (primary endpoint), as well as cumulative live birth, ovarian hyperstimulation syndrome (OHSS), and pregnancy loss rates. OPR/cycle start after fresh transfer was 35.5% with HP-hMG and 30.7% with rFSH (difference: 4.7%, 95% CI -2.7%, 12.1%); noninferiority was established. Compared to rFSH, HP-hMG was associated with significantly lower OHSS (21.4% vs. 9.7% respectively; difference: -11.7%, 95% CI -17.3%, -6.1%) and cumulative early pregnancy loss rates (25.5% vs. 14.5% respectively; difference: -11.0%, 95% CI -18.8%, -3.14%). Despite 43 more transfers in the rFSH group, cumulative live birth rates were similar with HP-hMG and rFSH at 50.6% and 51.5% respectively (difference: -0.8%, 95% CI -8.7%, 7.1%). In high responders, HP-hMG provided comparable efficacy to rFSH with fewer adverse events, including pregnancy loss, suggesting its optimized risk/benefit profile in this population. NCT02554279 (clinicaltrials.gov).

Menotrophin Induced Autoimmune Hepatitis.

Menotrophin is a protein-based hormonal therapy. It is used as a fertility medication that is given as injection either subcutaneously or intramuscularly. Menotrophin has not been previously reported to cause drug-induced liver injury. Drug-induced liver injury (DILI) is commonly seen nowadays with the expansion of the drug industry. It is associated with prescribed medications, over the counter drugs, herbal and dietary supplements. We report the first case of Menotrophin-induced autoimmune hepatitis in a 26-year-old Caucasian woman who was diagnosed with primary infertility due to failure to conceive after five years of marriage. She had received several cycles of Menotrophin, then developed new onset jaundice and fatigue associated with increase in transaminases. She had normal baseline liver function and enzymes prior to receiving treatment with Menotrophin. Evaluation showed no evidence of viral hepatitis, metabolic, alcoholic or vascular causes of liver injury. Autoimmune screening was positive for antinuclear antibody (ANA) with titer of 1 : 640 fine speckled, immunoglobulin G (IgG) level was 1900 mg/dl. Antimitochondrial antibodies (AMA) and antismooth muscle antibodies were negative. Liver biopsy showed features of chronic hepatitis with interface hepatitis and prominence of plasma cells, which best reflects autoimmune hepatitis. Her liver enzymes and bilirubin completely normalized after discontinuation of further Menotrophin therapy and starting treatment with prednisolone and Azathioprine.

Human menopausal gonadotropin (HMG) combined different doses of letrozole for treating anovulatory infertility in patients with polycystic ovary syndrome: a randomized controlled trial.

To optimize ovulation induction protocols for infertile women with PCOS, ovulation effect and adverse reactions of different doses of letrozole (2.5 vs 5.0 mg) combined sequentially HMG therapy were compared in infertility PCOS patients. This open-label randomized controlled trial (RCT) included 174 infertile women aged 18-40 who met the Rotterdam criteria for PCOS at the Wuhan Union Hospital of China from May 2021 to January 2022. They were randomly assigned at a 1:1 ratio to 2.5 mg LE or 5.0 mg LE on cycle days 3-7 with sequential HMG injections (n = 87 for each). There is no difference in ovulation rate between LE (2.5 mg) + HMG group and LE (5.0 mg) + HMG group in infertile women with PCOS (85.1 vs 85.1%). The ongoing pregnancy rate was no different between the two groups (33.3 vs 25.3%). The percentage of type B endometrial tissues on HCG injection day was higher in the LE (2.5 mg) + HMG group (88.5% vs 69.0%). The monofollicular development rate was significantly higher in the LE (2.5 mg) + HMG group (67.8% vs. 46.0%). Application of 5.0 mg LE followed with HMG does not improve the pregnancy rate compared to 2.5 mg LE in infertile women with PCOS. An increased dose of LE to 5.0 mg may increase the risks of OHSS and multiple pregnancies. Therapy of LE (2.5 mg) + HMG may be a more beneficial and optimal treatment protocol for improving endometrial receptivity and promoting mono-follicle development for patients with PCOS.

Oocyte donation.

Use of donor oocytes is becoming an increasingly important facet of assisted reproductive technology programs. Candidates for donor oocytes include women with premature ovarian failure or severe genetic disorders, women who respond poorly to human menopausal gonadotropin, and women older than 40 years who do not conceive with used of other therapies. The coordination of donor and recipient of oocytes is facilitated by pituitary desensitization of both parties using gonadotropin-releasing-hormone agonists. Pregnancy rates are much higher than that achieved with traditional in vitro fertilization and embryo transfer, possibly because of the young age of the donors and better endometrial receptivity.

Induction Of ovulation.

Sixty-one patients with anovulation as a cause of infertility were selected for our study. Various ovulation-inducing drugs were used like clomiphene citrate, human menopausal gonadotropin (hMG), human chorionic gonadotropin (hCG), bromergocryptine and leptadene. The response of the different drugs was observed by serial sonography for ovulation. Indeed there was a good response to clomiphene citrate, but those patients who failed to respond to clomiphene citrate and were frustrated with the use of hMG and hCG due to the cost and the complications of the therapy were put on Aloe compound and leptadene - an ayurvedic drug which enhances fertility in different ways.

Retrospective analysis: The application of human menopausal gonadotropin combined with letrozole for IUI in patients undergoing artificial insemination by husband due to unexplained or mild male factors.

To compare the effects of human menopausal gonadotropin (HMG) combined with letrozole (LE) to HMG only for ovarian stimulation on pregnancy outcome of infertile patients undergoing artificial insemination by husband (AIH) due to unexplained or mild male factors. Infertile patients with unexplained or mild male factors treated from July 2015 to December 2021 were selected as subjects. The patients were divided into two groups according to the ovarian stimulation schemes they received, namely HMG combined with LE or HMG only. We analyzed the laboratory examination results before drug treatment (baseline) and during ovarian stimulation and compared the pregnancy outcomes of the two groups using univariable analysis and multivariable logistic regression analysis. In total, 526 cycles of 372 couples were included. The univariate analysis showed that the clinical pregnancy rate of the HMG combined with LE group was 24.8%, significantly higher than that of the HMG group (14.8%, P = 0.007). The live birth rate (19.9%) of the HMG combined with LE group were also significantly higher than those of the HMG group (11.2%, respectively). In multivariate logistic analysis, the age of males was negatively associated with the clinical pregnancy rate (OR 0.874, 95% CI 0.793~0.963, P=0.006) and live birth (OR0.875, 95% CI 0.783~0.977, P=0.018). Moreover, ovarian stimulation with HMG+LE was the only beneficial factor significantly associated with clinical pregnancy (OR 1.929, 95% CI 1.068~3.485, P=0.029) and live birth (OR 2.255, 95% CI 1.188~4.282, P=0.013). Ovarian stimulation using HMG combined with LE can increase the clinical outcomes (live birth and clinical pregnancy) among infertile patients undergoing AIH due to explained or mild male factors.

Advantages of Recombinant Follicle-Stimulating Hormone over Human Menopausal Gonadotropin in Intrauterine Insemination: A Randomized Clinical Trial in Polycystic Ovary Syndrome-Associated Infertility.

Various gonadotropin preparations have been used for ovarian stimulation in intrauterine insemination (IUI). The purpose of the current study was to compare human menopausal gonadotropin (hMG) and recombinant follicle-stimulating hormone (rFSH) combined with clomiphene citrate (CC) in IUI cycles for polycystic ovary syndrome-associated infertility. In this prospective trial, couples prepared for IUI cycles were randomly allocated either to receive CC and rFSH (group A, n = 132) or CC and hMG (group B, n = 144) for ovarian stimulation. Outcomes including rates of clinical pregnancy, miscarriage, ovarian hyperstimulation syndrome, multiple pregnancy, cancellation and live birth were compared. The duration of gonadotropin therapy was shorter and total doses of gonadotropins was lower in the rFSH group. The number of stimulated follicles reaching >17 mm diameter was comparable between groups, but the mean follicular diameter was significantly higher in the rFSH group. The endometrium was also significantly thicker at the time of human chorionic gonadotropin administration in the rFSH group. However, pregnancy outcomes, including the rates of clinical pregnancy, ongoing pregnancy, live birth, miscarriage, ovarian hyperstimulation syndrome and cancellation, were similar between groups. IUI cycles in which rFSH is administered may result in shorter duration of treatment, a lower total gonadotropin dose and better follicular and endometrial characteristics on the day of human chorionic gonadotropin injection.

Male hyperprolactinemia:effects on fertility.

Male hyperprolactinemia was detected in 4% (7 of 171) of infertile men. In seven patients with excessive serum prolactin concentrations, the clinical manifestations were infertility, hypogonadism, impotence, and galactorrhea and the etiologic factors were pituitary adenoma, hypothalamic dysfunction, drug use, and idiopathic. The testes and prostate were small or normal and the semen analysis revealed low semen volume, normal or low sperm count, and normal or impaired sperm motility. The testicular biopsy showed normally preserved seminiferous tubules with normal or decreased spermatogenesis and damaged or fibrotic seminiferous tubules among normal ones. Patients with hyperprolactinemia were investigated by sellar polytomography, visual field examinations, and hormone assays. Treatment with bromocriptine (Parlodel) gave satisfactory results in all patients. The use of bromocriptine with human menopausal gonadotropin and human chorionic gonadotropin was beneficial in treating hypogonadotropic hypogonadism with hyperprolactinemia.

Economic evaluation of highly purified human menotropin or recombinant follicle-stimulating hormone for controlled ovarian stimulation in high-responder patients: analysis of the Menopur in Gonadotropin-releasing Hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial.

To determine the cost of achieving a live birth after first transfer using highly purified human menotropin (HP-hMG) or recombinant follicle-stimulating hormone (FSH) for controlled ovarian stimulation in predicted high-responder patients in the Menopur in Gonadotropin-releasing hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial. Cost minimization analysis of trial results. Thirty-one fertility centers. Six hundred and nineteen women with serum antimüllerian hormone ≥5 ng/mL. Controlled ovarian stimulation with HP-hMG or recombinant FSH in a gonadotropin-releasing hormone (GnRH) antagonist assisted reproduction cycle where fresh transfer of a single blastocyst was performed unless ovarian response was excessive whereupon all embryos were cryopreserved and patients could undergo subsequent frozen blastocyst transfer within 6 months of randomization. Mean cost of achieving live birth after first transfer (fresh or frozen). First-transfer efficacy, defined as live birth after first fresh or frozen transfer, was 54.5% for HP-hMG and 48.0% for recombinant FSH (difference 6.5%). Average cost to achieve a live birth after first transfer (fresh or frozen) was lower with HP-hMG compared with recombinant FSH. For fresh transfers, the cost was lower with HP-hMG compared with recombinant FSH. The average cost to achieve a live birth after first frozen transfer was also lower in patients treated with HP-hMG compared with recombinant FSH. Treatment of predicted high-responders with HP-hMG was associated with lower cost to achieve a live birth after first transfer compared with recombinant FSH. NCT02554279.

Human menopausal gonadotropin-induced bioprosthetic valve thrombosis.

Bioprosthetic valve thrombosis (BPVT) is a rare but potentially life-threatening complication. Human menopausal gonadotropin (hMG) is commonly used for ovulation induction and has been associated with arterial and venous thrombosis. We reported a case of BPVT related to in vitro fertilization in a 39-year-old female, who underwent redo mitral valve replacement. To the best of our knowledge, this is the first case of hMG-induced BPVT in a young female patient.

Highly Purified Human Menopausal Gonadotropin (Menopur®): A Profile of Its Use in Infertility.

Menopur® is a highly purified, urine-derived, human menopausal gonadotropin containing both follicle stimulating hormone (FSH) and luteinizing hormone (LH) activity. It is an effective option for controlled ovarian stimulation (COS) in assisted reproductive technology protocols and for ovulation induction (OI) in anovulatory infertility, and is associated with a different endocrine profile from that of recombinant (r) FSH in these settings (in terms of serum levels of FSH, androgens and/or estradiol). When used for COS in women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI), Menopur® was as good as rFSH in terms of pregnancy rates (despite being associated with a lower oocyte yield) and was found to improve some aspects of embryo quality in the IVF (but not ICSI) setting; using Menopur® in combination with highly purified urinary FSH resulted in similar reproductive outcomes as Menopur® alone. Data for Menopur® in OI are limited, but suggest ovulation rates may be as good as those with rFSH + rLH (in type 1 anovulation) and rFSH (in type 2 anovulation). Moreover, compared with rFSH, Menopur® appeared to be associated with a less pronounced follicular response and a lower risk of ovarian overstimulation.

Human recombinant follicle stimulating hormone (rFSH) compared to urinary human menopausal gonadotropin (HMG) for ovarian stimulation in assisted reproduction: a literature review and cost evaluation.

Gonadotropins are protein hormones which are central to the complex endocrine system that regulates normal growth, sexual development, and reproductive function. There is still a lively debate on which type of gonadotropin medication should be used, either human menopausal gonadotropin or recombinant follicle-stimulating hormone. The objective of the study was to perform a systematic review of the recent literature to compare recombinant follicle-stimulating hormone to human menopausal gonadotropin with the aim to assess any differences in terms of efficacy and to provide a cost evaluation based on findings of this systematic review. The review was conducted selecting prospective, randomized, controlled trials comparing the two gonadotropin medications from a literature search of several databases. The outcome measure used to evaluate efficacy was the number of oocytes retrieved per cycle. In addition, a cost evaluation was performed based on retrieved efficacy data. The number of oocytes retrieved appeared to be higher for human menopausal gonadotropin in only 2 studies while 10 out of 13 studies showed a higher mean number of oocytes retrieved per cycle for recombinant follicle-stimulating hormone. The results of the cost evaluation provided a similar cost per oocyte for both hormones. Recombinant follicle-stimulating hormone treatment resulted in a higher oocytes yield per cycle than human menopausal gonadotropin at similar cost per oocyte.

WITHDRAWN: Follicle-stimulating hormone and human menopausal gonadotropin for ovarian stimulation in assisted reproduction cycles.

Both human menopausal gonadotropin (hMG) and human follicle stimulating hormone (hFSH) have been used successfully for ovarian stimulation, but the relative importance of FSH and luteinizing hormone (LH) in follicular growth and maturation has been the subject of much debate. To conduct a systematic overview of available data comparing FSH and hMG in IVF treatment cycles. This review has drawn on the search strategy developed for the Menstrual Disorders & Subfertility Group as a whole. Relevant trials were identified in the Group's Specialised Register of Controlled Trials. See Review Group details for more information. Randomised controlled trials or quasi randomised controlled trials of ovarian stimulation with either hFSH or hMG, in combination with GnRHa or alone, in IVF treatment cycles. Common odds ratios (OR) were calculated after demonstrating homogeneity of treatment effect across all trials. Clinical pregnancy rates per cycle started, per cycle reaching oocyte retrieval, and per cycle reaching embryo transfer (ET). Eight trials met the inclusion criteria. The overall OR in favour of FSH for cycle start, oocyte retrieval, and ET were 1.70 (95% CI, 1.11-2.60), 1.68 (95% CI, 1.10-2.56), and 1.69 (95% CI, 1.10-2.59), respectively. This meta-analysis demonstrates that in IVF cycles the use of FSH is associated with a significantly higher clinical pregnancy rate than hMG.

Pharmacokinetics and Pharmacodynamics of Follicle-Stimulating Hormone in Healthy Women Receiving Single and Multiple Doses of Highly Purified Human Menotrophin and Urofollitrophin.

Highly purified human menotrophin and urofollitrophin preparations obtained from human urine via a novel patented purification method have been tested over a timeframe of 14 years in the studies presented in this article. The objective of the studies was to investigate the pharmacokinetics and the pharmacodynamics of follicle-stimulating hormone (FSH) after single subcutaneous and intramuscular doses and multiple subcutaneous doses of the tested preparations in healthy fertile pituitary-suppressed women. We performed five open, randomised, crossover, single-dose bioequivalence and/or bioavailability studies and one open, multiple-dose, pharmacokinetics and pharmacodynamics study. The six studies included 121 healthy fertile women taking their usual combined oral contraceptives for 3 months before the study: Study 1: 300 international units (IU) of highly purified menotrophin as single subcutaneous and intramuscular doses. Study 2: 300 IU of highly purified menotrophin (test formulation vs. comparator) as single subcutaneous doses. Study 3: 300 IU of highly purified urofollitrophin (hp-FSH) (test formulation vs. comparator) as single subcutaneous doses. Study 4: 300 IU (2 × 150 IU vs. 4 × 75 IU) of hp-FSH as single subcutaneous doses. Study 5: 225 and 445 IU of hp-FSH as single subcutaneous doses. Study 6: daily 225 IU of hp-FSH as subcutaneous doses for 5 consecutive days. The main outcome measures were the FSH pharmacokinetic parameters, estradiol concentrations, and the number and size of the follicles. FSH after single subcutaneous and intramuscular injections of menotrophin or urofollitrophin attained a systemic peak (maximum) concentration (C max) that was on average consistent throughout the first four studies and ranged from 4.98 to 7.50 IU/L. The area under the plasma concentration-time curve (AUC) from administration to the last observed concentration time t (AUCt) ranged from 409.71 to 486.16 IU/L·h and the elimination half-life (t ½) ranged from 39.02 to 53.63 h. After multiple doses of urofollitrophin (225 IU) for 5 days, FSH attained a mean C max of 14.93 ± 2.92 IU/L and had an AUC during the time interval τ between two consecutive doses at steady state (AUCτ) of 322.59 ± 57.92 IU/L·h, which was similar to the mean AUCt after a single subcutaneous dose of 225 IU of urofollitrophin in study 5 (306.82 ± 68.37 IU/L·h). In our studies, the intramuscular and subcutaneous routes of menotrophin were equivalent; both menotrophin and urofollitrophin were bioequivalent to their marketed reference; FSH kinetic parameters following injection of urofollitrophin were dose proportional and independent from the administered concentration; and multiple doses of FSH increased estradiol levels and enhanced growth of follicles with a good dose-response correlation. Local tolerability was excellent throughout the six studies.

Synchronization of estrus using progesterone injections followed by human menopausal gonadotropin in ewes.

Serial progesterone injections followed by human menopausal gonadotropin (hMG), instead of equine chorionic gonadotropin (eCG), were used to synchronize estrus in ewes. Shal ewes (n = 189) were assigned into five groups and each group was divided into two sub-groups to receive gonadotropins including eCG (300 IU; intra-muscular) or hMG (one ampoule; subcutaneously, SC). All ewes received prostaglandin (PG) F2α six days after introducing ram (day 0). Ewes received 0 (control), one, two, three or four injections of progesterone (50.00 mg; SC), 72 hr apart. The first progesterone was injected at the time of PG injection. Ewes in treatment groups received gonadotropins 48 hr after the last progesterone injection. Control group ewes received gonadotropins, at the time of PG injection. Mating was recorded after introducing fertile rams. Data were analyzed using GLM and GENMOD procedures in SAS. The incidence of estrus was less in control and ewes received a single progesterone (34.20%) compared to ewes received two (64.10%), three (81.10%) and four injections (68.40%) of progesterone. Time to estrus was earlier in control (45.70 ± 4.41 hr) than progesterone-treated groups (63.60 ± 1.79 hr). Fertility (51.30%) and fecundity (78.40%) of ewes received three progesterone injections were significantly greater than other progesterone-treated groups. There was no significant difference in reproductive indices between eCG and hMG sub-groups. In conclusion, during the non-breeding season, three injections of progesterone, three days apart, starting six days after ram exposure, in association with hMG, 48 hr after the last progesterone injection, could provide a sound reproductive performance in Shal ewes.

Standardization of therapeutic, urinary gonadotrophins: an update on the use and availability of International Standards for Menotrophin.

The potencies of therapeutic preparations of gonadotrophins of human, urinary origin, which comprise a heterogenous mix of isoforms with follicle-stimulating hormone (FSH) and luteinizing hormone (LH) bioactivities, are standardized by WHO International Standards (IS). We report here, the evaluation, through an international collaborative study, of a candidate preparation, coded 10/286, to replace the 4th IS, 98/704, for human, urinary FSH and LH (Menotrophin) which has been used for many years for the potency assignment of therapeutic preparations using bioassays. The mean FSH and LH bioactivities of 10/286, determined by in vivo bioassays in terms of 98/704, were 183 IU per ampoule (95% confidence limits 165-202) and 177 IU per ampoule (95% confidence limits 159-197), respectively.

Initial investigations into the hormonal basis of spermatogenesis.

MacLeod J, Pazianos A, Ray B. The restoration of human spermatogenesis and of the reproductive tract with urinary gonadotropins following hypophysectomy. Fertil Steril 1966;17(1):7-23. "No precedent was available in the male for the amount of [human menopausal gonadotropin] to be given in order to initiate spermatogenesis, if the latter could be done at all." "In this experiment, the evidence is strongly in favor of FSH activity being exerted first at the level of the spermatogonium, inducing mitosis and proliferation of this cell."

Efficacy of Follicle-Stimulating Hormone (FSH) Alone, FSH + Luteinizing Hormone, Human Menopausal Gonadotropin or FSH + Human Chorionic Gonadotropin on Assisted Reproductive Technology Outcomes in the "Personalized" Medicine Era: A Meta-analysis.

Luteinizing hormone (LH) and human chorionic gonadotropin (hCG) act on the same receptor, activating different signal transduction pathways. The role of LH or hCG addition to follicle-stimulating hormone (FSH) as well as menopausal gonadotropins (human menopausal gonadotropin; hMG) in controlled ovarian stimulation (COS) is debated. To compare FSH + LH, or FSH + hCG or hMG vs. FSH alone on COS outcomes. A meta-analysis according to PRISMA statement and Cochrane Collaboration was performed, including prospective, controlled clinical trials published until July 2016, enrolling women treated with FSH alone or combined with other gonadotropins. Trials enrolling women with polycystic ovarian syndrome were excluded (PROSPERO registration no. CRD42016048404). Considering 70 studies, the administration of FSH alone resulted in higher number of oocytes retrieved than FSH + LH or hMG. The MII oocytes number did not change when FSH alone was compared to FSH + LH, FSH + hCG, or hMG. Embryo number and implantation rate were higher when hMG was used instead of FSH alone. Pregnancy rate was significantly higher in FSH + LH-treated group vs. others. Only 12 studies reported live birth rate, not providing protocol-dependent differences. Patients' stratification by GnRH agonist/antagonist identified patient subgroups benefiting from specific drug combinations. In COS, FSH alone results in higher oocyte number. HMG improves the collection of mature oocytes, embryos, and increases implantation rate. On the other hand, LH addition leads to higher pregnancy rate. This study supports the concept of a different clinical action of gonadotropins in COS, reflecting previous in vitro data.

Clinical outcomes following long GnRHa ovarian stimulation with highly purified human menopausal gonadotropin plus rFSH or rFSH in patients undergoing in vitro fertilization-embryo transfer: a multi-center randomized controlled trial.

This clinical trial aimed to compare the clinical efficacy of highly purified human menopausal gonadotropin (HP-HMG) plus recombinant human follicle-stimulating hormone (rFSH) versus rFSH alone on controlled ovarian stimulation (COS) in vitro fertilization-embryo transfer (IVF-ET). A total of 610 women underwent long gonadotropin-releasing hormone (GnRH) agonist protocol for IVF treatment. The subjects were randomized into 2 groups: HP-HMG + rFSH group (n=305) and rFSH group (n=305). The main outcome was the progesterone (P) level on the day of HCG injection. There was no significant difference in terms of the demographic and baseline characters between the two groups. In rFSH group, the P level on the day of HCG trigger were significantly higher than that of HP-HMG+rFSH group (4.3&#xb1;2.2 vs. 3.8&#xb1;1.7 nmol/L, P<0.001). The fertilization rate in rFSH group was significantly lower than that of HP-HMG + rFSH group (69.2% vs. 73.9%, P<0.001). Simultaneously, the percentage of cycles with fresh embryo transfer in rFSH group was also significantly lower than that of HP-HMG + rFSH group (49.6% vs. 57.5%, P=0.007). However, there was no difference in terms of cleavage rate, implantation rate, clinical pregnancy rate and ovarian hyperstimulation syndrome (OHSS) rate between two groups. The use of combined HP-HMG with FSH may be superior to rFSH alone in stimulating the ovary in normal responders undergoing IVF treatment. Furthermore, the further prospective studies with large sample are still needed to confirm the study.

The possible effect of human menopausal gonadotropin on the audio-vestibular system.

Human menopausal gonadotropin (HMG) is one of the commonest drugs used for ovarian stimulation with no reports on the audio-vestibular system. This study aims to examine HMG on the hearing profile of patients planning intracytoplasmic sperm injection (ICSI). This prospective study was conducted from June 2016 to June 2017 in a tertiary referral hospital. The audio-vestibular system of a total of 30 patients was evaluated using pure tone audiometry, distortion product otoacoustic emissions (DPOAEs in the form of a DP-gram) and Vestibular-evoked myogenic potential (VEMP) immediately before therapy and at the day 10 after therapy. Audio-vestibular adverse effects including hearing loss, tinnitus, vertigo, and otalgia were also considered. Significant elevations in hearing thresholds were found on comparing thresholds at the day 10 at the onset of the study. The elevations were mostly at frequencies (1000, 2000 and 8000Hz) and did not affect speech perception. For DPOAE, significant differences were observed at all F2 frequencies on comparing both amplitudes and signal to noise ratios. Otologic complaints were significant for tinnitus and hearing loss. Significant auditory and vestibular adverse effects may result from HMG therapy, indicating the importance of prompt monitoring of auditory functions in these patients.

Comparing highly purified human menopausal gonadotropin and recombinant follicle stimulating hormone in poor ovarian reserve patients undergoing intracytoplasmic sperm injection.

We aimed to compare highly purified human menopausal gonadotropin (hp-hMG) and recombinant follicle stimulating hormone (rFSH) in short antagonist in&#x2005;vitro fertilization (IVF) cycles of patients with poor ovarian reserve (POR). Limited research exists on this comparison in short antagonist cycles for this patient group. This retrospective cohort study involved 165 POR patients aged 18-45 years who underwent IVF between 2018 and 2022. Patients were divided into two groups based on their GnRH antagonist protocol: hp-hMG (group 1 = 72) and rFSH (group 2 = 93). We compared pregnancy outcomes, number of oocytes collected, mature oocytes retrieved, mean fertilized oocytes, top quality embryos transferred, and serum estradiol (E2) and progesterone (P) levels on human chorionic gonadotropin (hCG) administration day. : No significant differences were found in E2 and P levels on hCG trigger day, endometrial thickness on transfer day, stimulation duration, total oocyte number, and mature oocyte number (P > 0.05). The total gonadotropin dose was significantly higher in the rFSH group (P < 0.001). The number of top-quality embryos transferred and clinical pregnancy and live birth rates did not diff er significantly between groups (P = 0.320; P = 0.310; P = 0.652; and P = 0.662, resp.). Neither hp-hMG nor rFSH showed superiority in patients with POR, indicating similar effectiveness in this population.

Prospective randomized study of human menotropin versus a follicular and a luteal phase gonadotropin-releasing hormone analog-human menotropin stimulation protocols for in vitro fertilization.

To determine whether gonadotropin-releasing hormone analogs (GnRH-a) initiated either in the luteal phase or in the early follicular phase immediately preceding menotropin will improve the fertilization, implantation, and pregnancy rates (PR) in all IVF patients, when compared with menotropins alone. In a prospective, controlled, randomized study we compared a pure follicle-stimulating hormone (FSH) human menopausal gonadotropin (hMG) protocol (group A = control) (n = 93 cycles) to two protocols in which GnRH-a pretreatment plus pure FSH and/or hMG was used in in vitro fertilization candidates. In group B (n = 64) GnRH-a was initiated during the luteal phase and in group C (n = 35) during the follicular phase. We found (1) no differences in fertilization and implantation rates between the three protocols; (2) similar pregnancy rates per transfer when similar number of conceptus were transferred (A = 30%, B = 22%, C = 21%); (3) an increase of the number of oocytes obtained; and (4) a reduction in the cancellation rate with both GnRH-a protocols. These findings suggest that there is no obvious superiority between the two GnRH-a protocols in the dosage schedule used and that the major advantage of GnRH-a over non-GnRH-a protocols is in decreasing the cancellation rate and increasing the number of oocytes and conceptus obtained. The follicular phase GnRH-a protocol required less hMG-pure FSH than the luteal phase GnRH-a protocol.

Implantation, abortion, and birth after in vitro fertilization using the natural menstrual cycle or follicular stimulation with clomiphene citrate and human menopausal gonadotropin.

The incidence of pregnancy and abortion was analyzed in 1679 patients having embryos replaced after oocyte recovery and in vitro fertilization in order to alleviate their infertility. In these patients, 364 pregnancies were achieved and 108 abortions occurred. Patients were treated either on their natural cycle, having a spontaneous luteinizing hormone (LH) surge to induce ovulation, or after ovarian stimulation using clomiphene citrate alone or in combination with human menopausal gonadotropin (hMG). The data were assessed in relation to the numbers of embryos replaced, the follicular stimulation and ovulation induction regime used, the dose of gonadotropins and the dose of antiestrogens, and the age of the patient. The most successful treatment for the number of live births per laparoscopy was the use of clomiphene citrate in combination with human menopausal gonadotropin followed by human chorionic gonadotropin (hCG) to induce follicular maturation and ovulation. This treatment produced a significantly higher (P less than 0.001) number of patients with multiple embryos (86.5%). There was no significant effect on pregnancy or abortion with a low (less than 400-mg) or high (greater than or equal to 400-mg) dose of clomiphene. The total dose of gonadotropins used did not influence the incidence of pregnancy or abortion. The use of hCG with hMG induced a significant (P less than 0.01) positive effect on the incidence of pregnancy. The incidence of pregnancy showed a progressive decline with increasing age but there was a highly significant (P less than 0.01) increase in the incidence of abortion with increasing age. With increasing numbers of embryos replaced, up to three, the incidence of deliveries increased.(ABSTRACT TRUNCATED AT 250 WORDS)

Luteinizing hormone supplementation with human menopausal gonadotropin versus low dose human chorionic gonadotropin during ovarian stimulation does not affect live birth rates after fresh and frozen embryo transfer.

Luteinizing hormone (LH) plays an important role in ovarian follicle maturation. Human menopausal gonadotropin (hMG) or low dose human chorionic gonadotropin (hCG) can provide LH supplementation during in vitro fertilization (IVF) ovarian stimulation, though studies directly comparing their impact on IVF outcomes are limited. The aim of the study was to determine whether LH supplementation with hMG versus low dose hCG during IVF stimulation affects live birth rate. Fresh and frozen embryo transfers (ET) from 2017 to 2021 after standard long or antagonist protocols supplemented with hMG (75-250&#x2009;IU) or low dose hCG (50-100&#x2009;IU) during stimulation cycles in our academic center were included. Statistical analysis was performed with T-tests, Mann-Whitney U tests, Chi-square, and multiple linear and logistic regression. Four hundred and sixty eight unique stimulation cycles resulting in 213 fresh and 412 frozen embryo transfers were analyzed. There was a lower mature oocyte yield (10.9 vs. 11.8, p&#x2009;=&#x2009;0.044) but similar high-quality blastocyst yield (3.6 vs. 3.9, p&#x2009;=&#x2009;0.11) for hMG vs low dose hCG. Live birth rates per transfer were comparable for fresh (42% vs. 49%, p&#x2009;=&#x2009;0.24) and frozen (46% vs. 53%, p&#x2009;=&#x2009;0.45) embryo transfers. Multiple logistic regressions showed no association between supplemental gonadotropin and live birth for both fresh and frozen embryo transfers. Fresh and frozen IVF-ET pregnancy outcomes were comparable after hMG versus low dose hCG supplementation, suggesting flexibility in supplemental LH dosing regimens that may address patient or physician preference or cost concerns.

Comparison of recombinant human luteinising hormone (r-hLH) and human menopausal gonadotropin (hMG) in assisted reproductive technology.

Follicle-stimulating hormone (FSH) and luteinising hormone (LH) act in concert in the stimulation of folliculogenesis and ovulation. However, high levels of LH promote follicular atresia and early miscarriage, and this has led to the concept of a 'therapeutic window' of LH for successful conception in assisted reproductive technology (ART) and ovulation induction. Until now, urinary-derived human menopausal gonadotropin (hMG) has been the only available source of exogenous LH activity. hMG preparations contain highly variable levels of LH, and are often augmented with human chorionic gonadotropin (hCG), which mimics LH activity. Accumulation of hCG bioactivity, however, may have detrimental effects on follicular development and oocyte quality. Recombinant human LH (r-hLH) (Luveris) is the only pure source of LH activity. r-hLH is well characterised and production is tightly controlled, resulting in a highly consistent product. Clinical studies in hypogonadotropic hypogonadal women have demonstrated the efficacy of r-hLH, 75 IU/day, together with r-hFSH, 150 IU/day, in promoting optimal follicular development, oestrogen secretion and endometrial thickness. r-hLH therefore provides the clinician with the opportunity for precise and consistent dosing within the therapeutic window for patients requiring exogenous LH, without the risk of LH overexposure that is associated with hCG.

[Health economic consequences of the choice of follicle stimulating hormone alternatives in IVF treatment].

There is a choice between two types of hormones for stimulation of the follicles in IVF treatment - recombinant FSH and the urine-derived menotrophin. A literature review by NICE (2004) in the United Kingdom documented that the two types of hormones were equally effective and safe, which is why it was recommended to use the cheaper urine-derived hormone. Based on the EISG study (European and Israeli Study Group), the aim was to analyse the health economic consequences of the choice between the two types of hormone in IVF treatment in Denmark. In a prospective cost-effectiveness analysis (health care sector perspective), menotrophin and recombinant FSH (Gonal-F) were compared. Differences in costs were compared with differences in effects of the two alternatives. The total costs for the average patient are lower when using menotrophin compared with recombinant FSH. Furthermore, the cost per clinical pregnancy was lower with menotrophin compared with recombinant FSH hormone. Menotrophin is therefore less expensive both for the patient as well as for the health care sector. The use of menotrophin instead of recombinant FSH can result in savings of up to DKK 16 million on the drug budget--savings that could finance 1,400 additional IVF cycles. The analysis shows that urine-derived menotrophin is a cost-effective alternative to recombinant FSH with a potential for considerable savings for patients as well as the public drug budget.

Ovarian stimulation with clomiphene and/or human menopausal gonadotropin (HMG) for in vitro fertilization (IVF) and embryo transfer (ET).

Ultrasonographic and clinical correlates of menotropin versus sequential clomiphene citrate: menotropin therapy for induction of ovulation.

Forty-six women remaining infertile with clomiphene citrate (CC) with or without human chorionic gonadotropin (hCG) were treated by either human menopausal gonadotropin (hMG, 44 cycles) or CC + hMG (33 cycles) and monitored by serum estradiol (E2) and ultrasonography. Ovarian hyperstimulation syndrome (OHS) and pregnancy outcome were compared in both regimens. In the presence of dominant follicles (greater than or equal to 18 mm) alone or with a single secondary follicle (14 to 16 mm) at hCG administration, OHS did not develop. A significant increase in OHS was noted when three or more secondary follicles were observed. Overall pregnancy rates were similar in both regimens but significantly higher when hCG was injected before rather than after the E2 peak. The results suggest secondary follicles rather than dominant follicles are a valuable sign of possible OHS development; and CC + hMG should be considered in CC-failure patients.

Risk factors for spontaneous abortion in menotropin-treated women.

Women who conceive with human gonadotropins have a high rate of spontaneous abortions. The causes for this poor outcome are unknown. In a retrospective analysis, the authors analyzed potential factors in 45 menotropin-treated patients with spontaneous first-trimester miscarriages. Data were compared with 119 menotropin-treated patients who conceived and delivered viable infants. Patient factors that were analyzed included the following: age, history of past miscarriages, duration of infertility, diagnostic category, weight, body surface area, duration and weight-corrected dose of menotropin administration, maximum estradiol level, estradiol pattern, human chorionic gonadotropin (hCG) dose, presence or absence of hCG support in the luteal phase, results of postcoital testing, methods of insemination, and results of husband's semen analysis. There was a significant difference between the miscarriage group and the control group in regard to age and weight distribution. All other characteristics were not significantly different. Patients over 81.8 kg as well as patients aged 35 years and older were both significantly (P less than 0.01) at increased risk to have a spontaneous first-trimester miscarriage. The data suggest that obesity and advanced age contribute to the high miscarriage rate in menotropin-treated patients. It appears reasonable to suggest that women weighing more than 81.8 kg should make every effort to lose weight before beginning menotropin therapy.

Response: Commentary: Efficacy of Follicle-Stimulating Hormone (FSH) Alone, FSH&#x2009;+&#x2009;Luteinizing Hormone, Human Menopausal Gonadotropin or FSH&#x2009;+&#x2009;Human Chorionic Gonadotropin on Assisted Reproductive Technology Outcomes in the "Personalized" Medicine Era: A Meta-analysis.

Ovulation stimulation and induction.

Evaluation of gonadotropins, prolactin, and thyroid function in anovulatory women directs subsequent therapy. Treatment should be initiated with the agent that is the safest and least costly for the specific indication. Except in cases of FSH elevation, pregnancy rates should approximate those of normally ovulating women. Bromocriptine, the drug of choice for hyperprolactinemia, restores ovulation in greater than 90% of women treated. Clomiphene citrate remains the drug of choice for normoestrogenic anovulation. Although drug-resistant women may respond to extended regimens, failure to ovulate or to conceive within six ovulatory cycles with clomiphene is an indication for menotropin therapy. Menotropins and pulsatile GnRH should be considered first line therapy for women with hypogonadotropic anovulation. When using hMG or pulsatile GnRH in clomiphene-resistant patients, pretreatment with GnRH analogs may normalize their response and result in higher pregnancy rates. GnRH analogs prevent premature luteinization in hMG-induced in vitro fertilization and gamete intrafallopian transfer cycles, resulting in lower cancellation rates and improved oocyte quality. Superovulation with clomiphene citrate should be attempted in patients with unexplained infertility prior to using menotropin therapy.

Low- versus high-dose human menopausal gonadotropin in an in vitro fertilization-embryo transfer program.

Consecutive versus concomitant follicle-stimulating hormone and highly purified human menopausal gonadotropin: A milder response but better quality.

This study investigated the impact of two stimulation protocols using highly purified human menopausal gonadotropin (HP-hMG) on the endocrine profile, follicular fluid soluble Fas levels, and outcomes of intracytoplasmic sperm injection (ICSI) cycles. This prospective clinical trial included 100 normal-responder women undergoing ovarian stimulation for ICSI; 55 patients received concomitant follicle-stimulating hormone (FSH) plus HP-hMG from the start of stimulation, while 45 patients received FSH followed by HP-hMG during mid/late follicular stimulation. The primary outcome was the number of top-quality embryos. The secondary outcomes were the number and percentage of metaphase II (MII) oocytes and the clinical pregnancy rate. The number of MII oocytes was significantly higher in the concomitant protocol (median, 13.0; interquartile range [IQR], 8.5-18.0 vs. 9.0 [8.0-13.0] in the consecutive protocol; p=0.009); however, the percentage of MII oocytes and the fertilization rate were significantly higher in the consecutive protocol (median, 90.91; IQR, 80.0-100.0 vs. 83.33 [75.0-93.8]; p=0.034 and median, 86.67; IQR, 76.9-100.0 vs. 77.78 [66.7-89.9]; p=0.028, respectively). No significant between-group differences were found in top-quality embryos (p=0.693) or the clinical pregnancy rate (65.9% vs. 61.8% in the consecutive vs. concomitant protocol, respectively). The median follicular fluid soluble Fas antigen level was significantly higher in the concomitant protocol (9,731.0 pg/mL; IQR, 6,004.5-10,807.6 vs. 6,350.2 pg/mL; IQR, 4,382.4-9,418.4; p=0.021). Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI.

Follitropin delta combined with menotropin in patients at risk for poor ovarian response during in vitro fertilization cycles: a prospective controlled clinical study.

The maximum daily dose of follitropin delta for ovarian stimulation in the first in vitro fertilization cycle is 12&#x2009;&#x3bc;g (180&#x2009;IU), according to the algorithm developed by the manufacturer, and based on patient's ovarian reserve and weight. This study aimed to assess whether 150&#x2009;IU of menotropin combined with follitropin delta improves the response to stimulation in women with serum antimullerian hormone levels less than 2.1&#x2009;ng/mL. This study involved a prospective intervention group of 44 women who received 12&#x2009;&#x3bc;g of follitropin delta combined with 150&#x2009;IU of menotropin from the beginning of stimulation and a retrospective control group of 297 women who received 12&#x2009;&#x3bc;g of follitropin delta alone during the phase 3 study of this drug. The inclusion and exclusion criteria and other treatment and follow-up protocols in the two groups were similar. The pituitary suppression was achieved by administering a gonadotropin-releasing hormone (GnRH) antagonist. Ovulation triggering with human chorionic gonadotropin or GnRH agonist and the option of transferring fresh embryos or using freeze-all strategy were made according to the risk of developing ovarian hyperstimulation syndrome. Women who received follitropin delta combined with menotropin had higher estradiol levels on trigger day (2150&#x2009;pg/mL vs. 1373&#x2009;pg/mL, p&#xa0;<&#x2009;0.001), more blastocysts (3.1 vs. 2.4, p&#xa0;=&#x2009;0.003) and more top-quality blastocysts (1.8 vs. 1.3, p&#xa0;=&#x2009;0.017). No difference was observed in pregnancy, implantation, miscarriage, and live birth rates after the first embryo transfer. The incidence of ovarian hyperstimulation syndrome did not differ between the groups. However, preventive measures for the syndrome were more frequent in the group using both drugs than in the control group (13.6% vs. 0.6%, p&#xa0;<&#x2009;0.001). In women with serum antimullerian hormone levels less than 2.1&#x2009;ng/mL, the administration of 150&#x2009;IU of menotropin combined with 12&#x2009;&#x3bc;g of follitropin delta improved the ovarian response, making it a valid therapeutic option in situations where ovulation triggering with a GnRH agonist and freeze-all embryos strategy can be used routinely. U1111-1247-3260 (Brazilian Register of Clinical Trials, available at https://ensaiosclinicos.gov.br/rg/RBR-2kmyfm ).

Prion transmission in blood and urine: what are the implications for recombinant and urinary-derived gonadotrophins?

Evidence is emerging that suggests that the protease-resistant isoform (PrP(sc)) of the normal cellular prion protein (PrP(c)) can be detected in the blood and urine of animals and humans with transmissible spongiform encephalopathies (TSEs). The production of the human menopausal and recombinant gonadotrophin preparations for use in ovarian stimulation protocols in fertility treatment is one area where the pharmaceutical industry needs to be vigilant and take appropriate steps to ensure that the safety of such drugs remains as high as ever. The recombinant preparations utilize fetal calf serum or other animal sera or proteins as part of a culture medium during production. Human urinary-derived menotrophin preparations are exposed to the theoretical risk of infection from menopausal donors of urine. Nevertheless, the failure to demonstrate irrefutably infectivity following intracerebral inoculation with urine from TSE-infected hosts suggests that the risk associated with products derived from urine is merely theoretical. Despite the paucity of evidence to date and its relevance to the infectious spread of TSEs, it is important that robust measures are implemented to either remove or inactivate PrP(sc) in order to minimize contamination. Validation of each production process is required to assess the likelihood of contamination.

Follow-up of 32 hypothalamo-hypopituitary patients treated with pulsatile gonadotropin-releasing hormone or human menopausal gonadotropin.

In a clinical retrospective study, a follow-up of hypothalamo-amenorrheic patients treated firstly with gonadotropin-releasing hormone (GnRH) pump stimulation and secondly with human menopausal gonadotropin (hMG) was performed. Thirty-two hypothalamo-amenorrheic patients, 24-38 years old, were submitted to 103 GnRH stimulation cycles. Seven, with polycystic ovaries (PCO) on ultrasound, were stimulated with hMG after one or several unsuccessful pump cycles. Ovulation was confirmed by a luteinizing hormone (LH) surge or triggered by human chorionic gonadotropin in 80 out of 103 cycles (77.7%/cycle) leading to 62 timed sexual intercourses and 17 intrauterine inseminations (IUI). Twenty-one pregnancies (26.3%/cycle) terminated in eight abortions (38.1%/pregnancy) and 13 deliveries (40.6%/patient). hMG stimulation, in the seven PCO patients (six IVF, one IUI), led to four additional deliveries in three patients. Five patients became pregnant spontaneously after pump failure (n = 2) or unsuccessful IVF (n = 3). Combining all cycles, 17 deliveries were obtained in 16 patients. No case of ovarian hyperstimulation syndrome (OHSS) was observed. GnRH is an efficient and safe treatment of hypothalamo-amenorrheic-induced anovulation. Following GnRH or hMG ovarian stimulation, spontaneous ovulation and conception may be restored in certain hypothalamo-amenorrheic patients.

Ovulation induction in the new millennium: recombinant follicle-stimulating hormone versus human menopausal gonadotropin.

The renewed interest in luteinizing hormone (LH), together with limited and decreasing health resources, make essential the comparison of high-cost, recombinant follicle-stimulating hormone (rFSH) preparations (devoid of LH) and human menopausal gonadotropin (hMG) in terms of clinical efficacy. All published, randomized controlled trials (RCTs) comparing rFSH versus hMG under different protocols of stimulation were examined. Eight true RCTs were included in this meta-analysis, recruiting 2031 participants. Data for ongoing pregnancy/live birth rate, clinical pregnancy rate, miscarriage rate, multiple pregnancy rate and ovarian hyperstimulation syndrome (OHSS) were extracted, and odds ratios (ORs) and 95% confidence intervals (CIs) were calculated with the use of a fixed-effects model. Data for the meta-analysis were combined using RevMan software (using the Mantel-Haenszel method). Pooling the results of these RCTs showed no significant difference between rFSH and hMG regarding the different outcomes: ongoing pregnancy/live birth rate, OR 1.18 (95% CI 0.93-1.50); clinical pregnancy rate, OR 1.2 (95% CI 0.99-1.47), miscarriage rate, OR 1.2 (95% CI 0.70-2.16); multiple pregnancy rate, OR 1.35 (95% CI 0.96-1.90); incidence of moderate/severe OHSS, OR 1.79 (95% CI 0.74-4.33). However, there was significant reduction in the amount of gonadotropins in favor of hMG over rFSH. There was no significant heterogeneity of treatment effect across the trials. In conclusion, there is no clinically significant difference between hMG and rFSH in in vitro fertilization/intracytoplasmic sperm injection cycles. Decision-makers should establish their choice of one drug over the other based on the most up-to-date evidence available.

Human Menopausal Gonadotropin Commenced on Early Follicular Period Increases Live Birth Rates in POSEIDON Group 3 and 4 Poor Responders.

Human menopausal gonadotropin (hMG) has LH activity, and it may have beneficial effects in terms of oocyte quality and endometrial receptivity similar to recombinant LH supplementation. The aim of this study was to assess the effects of hMG, and its commencement time on the outcome of assisted reproductive technology (ART) cycles of POSEIDON group 3 and 4 poor responders. Data of 558 POSEIDON group 3 and 4 poor responders who underwent ART treatment following a GnRH antagonist cycle at a university-based infertility clinic between January 2014 and December 2019 were reviewed. hMG was commenced at the early follicular phase or mid-follicular phase in the study groups. The control group did not receive hMG stimulation. Live birth rate (LBR) was the main outcome measure. The mean duration of stimulation was significantly shorter in early follicular hMG group than in mid-follicular hMG group (11.9&#x2009;&#xb1;&#x2009;3.6&#xa0;days vs. 12.8&#x2009;&#xb1;&#x2009;4&#xa0;days, respectively; P&#x2009;=&#x2009;0.027). The mean numbers of oocytes retrieved and MII oocytes were comparable between the groups. The LBRs per embryo transfer in early follicular hMG, mid-follicular hMG, and control groups were 21.9%, 11.7%, and 11.6%, respectively (P&#x2009;=&#x2009;0.035). In conclusion, there is a significant association between the commencement time of hMG and live birth chance in ART cycles of POSEIDON group 3 and 4 poor responders. Early initiation of hMG together with rFSH seems to be beneficial in this specific population.

Female and male partner age and menotrophin requirements influence pregnancy rates with human menopausal gonadotrophin therapy in combination with intrauterine insemination.

This study analyses the influence of female and male patient age and human menopausal gonadotrophin (HMG) requirements on clinical pregnancy rates and live birth rates with ovulation stimulation using HMG in combination with intrauterine insemination (IUI). In this study, 363 consecutive HMG/IUI treatment cycles in 184 patients carried out at a university fertility centre were analysed in a retrospective fashion. The main outcomes measured were clinical pregnancy rates and live birth rates. Increased female partner age (> or = 35) and male partner age (> or = 40) were found to negatively influence pregnancy rates with HMG/ IUI therapy. In addition, this study demonstrated a critical threshold of HMG requirements beyond which pregnancy did not occur. No pregnancies occurred in treatment cycles requiring > 25 ampoules (1875 IU) of menotrophins to achieve follicular maturity, irrespective of patient age. In conclusion, female partner age, male partner age, and HMG requirements all significantly influence pregnancy rates with HMG/IUI therapy.

Subcutaneous human menopausal gonadotropin administration for controlled ovarian hyperstimulation with intrauterine insemination cycles.

This study was undertaken to determine the feasibility of administering human menopausal gonadotropin subcutaneously for controlled ovarian hyperstimulation with intrauterine insemination. This was a prospective nonrandomized matched-group comparison. Study patients (n = 25) undergoing controlled ovarian hyperstimulation with intrauterine insemination infertility treatment between June 1998 and March 1999 self-administered human menopausal gonadotropin subcutaneously for ovulation induction. Cycles (n = 39) were analyzed for duration of human menopausal gonadotropin treatment, total number of ampules of human menopausal gonadotropin used, peak serum estradiol level, number of mature follicles (> or =15 mm), cycle fecundity, and acceptability of the subcutaneous route of human menopausal gonadotropin administration. Age-matched historical control subjects who followed the same protocol except for the route of human menopausal gonadotropin administration, which was instead intramuscular, were used for comparison. Study and control cycles did not differ with respect to duration of human menopausal gonadotropin treatment (7.49 vs 8.18 d), total number of ampules of human menopausal gonadotropin used (17.44 vs 19.55), peak serum estradiol level (881 vs 769 pg/mL), number of mature follicles (>/=15 mm; 3.39 vs 2.92), or cycle fecundity rate (15.4% vs 17.9%). Two study patients were switched from subcutaneous to intramuscular administration because of minor local injection site reactions. Subcutaneous human menopausal gonadotropin administration for controlled ovarian hyperstimulation with intrauterine insemination treatment cycles was generally well tolerated and yielded stimulation parameters and pregnancy rates similar to those associated with the intramuscular route. Patients subjectively preferred subcutaneous human menopausal gonadotropin administration because of the ability to self-administer the injections, the use of a smaller injection needle, and reduced muscular pain at the injection site.