Menotropins
updated
Menotropins are used inside a monitored fertility sequence. Current US Menopur supports controlled ovarian stimulation in ovulatory women undergoing assisted reproduction. Its noninferiority live-birth comparison came from predicted high responders in one specific ICSI protocol, while older male findings used historical hMG only after hCG and do not create a current Menopur indication for men.
Urinary-derived FSH and LH activity mixture
- Menopur provides 75 IU of FSH activity and 75 IU of LH activity per reconstituted vial
- Ovarian response is monitored with ultrasound and sometimes estradiol
- Pregnancy, ongoing pregnancy, and live birth are different endpoints
Is this about current female ART treatment or historical male gonadotropin evidence?
The current US Menopur label is for developing multiple follicles and pregnancy in ovulatory women participating in an assisted-reproductive-technology cycle. It does not list a male indication. A 1985 male study addressed hypogonadotropic hypogonadism with staged hCG followed by historical hMG plus hCG, a different treatment question and product era.
Neither body of evidence studied libido or general hormone optimization. In female ART, menotropins are one part of a monitored stimulation, trigger, retrieval, fertilization, and transfer protocol. In the historical male study, hMG supplied FSH activity only after an hCG phase and remained combined with hCG.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceFinkel study · historical hCG plus hMG
Small uncontrolled staged clinical study
Finkel DM, Phillips JL, Snyder PJ. New England Journal of Medicine. 1985;313(11):651-655. doi:10.1056/NEJM198509123131102. PMID: 3927163.
After an hCG-only phase in 21 men, 14 prepubertal-onset nonresponders received historical hMG in addition to hCG; sperm counts normalized in five of seven without cryptorchidism and one of seven with it.
- Participants / model
- 21 men with hypogonadotropic hypogonadism; 14 prepubertal-onset nonresponders entered the combined hMG plus hCG stage
- Treatment
- Human chorionic gonadotropin first, then historical human menopausal gonadotropin added for selected nonresponders
- Follow-up
- Not reported in the public abstract
- Study design
- Small staged uncontrolled physiologic replacement study
- Funding
- US Public Health Service grant support listed in PubMed
The hMG effect cannot be separated from continued hCG. The abstract does not establish a current Menopur product, route, dose, or male indication.
Read the original sourceIs menotropins one molecule or a measured biologic mixture?
It is a biologic mixture described by activity rather than one pure small-molecule mass. After reconstitution, each Menopur vial supplies 75 IU of FSH activity and 75 IU of LH activity. The label says human chorionic gonadotropin is detected in the product and contributes to LH activity.
| Product term | What it supplies | Use of evidence |
|---|---|---|
| Menopur / HP-hMG | Urinary-derived FSH and LH activity; hCG is detectable | Use Menopur-specific label and trial data when claiming product outcomes |
| Recombinant FSH | Recombinant FSH without the same urinary mixture | An active comparator, not the same ingredient |
| Purified urinary FSH | FSH-focused urinary product | Do not assume the Menopur composition or trial result |
| hCG trigger | Separate LH-receptor signal used after adequate maturation | A protocol step, not stronger Menopur |
Activity units do not make brands or biologic mixtures automatically interchangeable.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceFDA SRS · menotropins identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Menotropins, UNII 5Y9QQM372Q.
Provides the official substance name, aliases, CAS, and UNII for the biologic mixture.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
Substance registration does not establish product approval, interchangeability, clinical efficacy, or a single molecular formula.
Read the original sourceAt which ART stage does menotropins act, and where are outcomes counted?
Menotropins stimulate follicular development. Ultrasound and estradiol measurements guide the response. After adequate maturation, a separate trigger is given; oocytes are retrieved, fertilized, and then transferred fresh or after freezing. Follicle count sits near the beginning of that chain. Live birth sits at the end.
| Stage | What is measured | What it does not guarantee |
|---|---|---|
| Stimulation | Follicles, estradiol, ovarian response | A mature oocyte |
| Trigger and retrieval | Oocytes retrieved | Fertilization or embryo quality |
| Fertilization and culture | Embryos and blastocysts | Implantation |
| Transfer | Fresh or frozen embryo transfer | Ongoing pregnancy |
| Pregnancy follow-up | Clinical or ongoing pregnancy | Live birth |
| Birth | Live birth per transfer or per cycle start | The same result in another protocol or population |
Rates change with the denominator. A live-birth rate per transfer excludes cycles that never reached transfer, while a cumulative rate per cycle start can include later frozen transfers. These percentages cannot be compared without their stage and denominator.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceMEGASET-HR · outcome funnel
Randomized assessor-blinded noninferiority trial
Witz CA et al. Fertility and Sterility. 2020;114(2):321-330. doi:10.1016/j.fertnstert.2020.03.013. PMID: 32416978.
In 620 predicted high responders, HP-hMG was noninferior to recombinant FSH for ongoing pregnancy after fresh transfer; OHSS and early pregnancy loss were lower, while six-month cumulative live birth was 50.6% versus 51.5%.
- Participants / model
- 620 ovulatory women aged 21 to 35 with AMH at least 5 ng/mL; 619 treated
- Treatment
- HP-hMG or recombinant FSH in a GnRH-antagonist ICSI cycle with fresh single-blastocyst transfer or freeze-all for excessive response and frozen transfer follow-up
- Follow-up
- One stimulation cycle with eligible frozen transfers within six months
- Study design
- Randomized open-label, assessor-blinded, parallel-group noninferiority trial
- Funding
- Ferring Pharmaceuticals; sponsor-affiliated authors
The primary question was noninferiority, not superiority. Results depend on a selected high-responder population and protocol, and the recombinant-FSH group underwent 43 more transfers.
Read the original sourceWhat did the pivotal Menopur trial measure after one stimulation cycle?
The label summarizes an open-label multinational IVF or IVF-ICSI comparison after pituitary suppression. It randomized 373 women to Menopur and found continuing pregnancy in 87, or 23%, and clinical pregnancy in 98, or 26%. Continuing pregnancy was defined by a gestational sac with fetal heartbeat at at least ten weeks after embryo transfer.
The primary continuing-pregnancy result was noninferior to recombinant human FSH. The study was not powered to show a difference in the secondary clinical-pregnancy endpoint. OHSS occurred in 7.2% of Menopur recipients. Among diagnosed pregnancies, 35.3% were multiple pregnancies, which uses a pregnancy denominator rather than all randomized women.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceWhich arms and protocol produced the 50.6% versus 51.5% live-birth result?
MEGASET-HR randomized 620 ovulatory women aged 21 to 35 with AMH at least 5 ng/mL, a predicted high-responder population. In a GnRH-antagonist ICSI cycle, 310 treated participants received highly purified hMG and 309 received recombinant FSH. Cumulative live birth per cycle start, including eligible frozen transfers within six months, was 50.6% versus 51.5%, a difference of -0.8 percentage points with a 95% confidence interval from -8.7 to 7.1.
| Outcome | HP-hMG | Recombinant FSH | Interpretation |
|---|---|---|---|
| Ongoing pregnancy after fresh transfer per cycle start | 35.5% | 30.7% | Primary endpoint; difference 4.7 points, 95% CI -2.7 to 12.1; noninferiority established, superiority not established |
| OHSS | 9.7% | 21.4% | Difference -11.7 points, 95% CI -17.3 to -6.1 |
| Cumulative early pregnancy loss | 14.5% | 25.5% | Difference -11.0 points, 95% CI -18.8 to -3.14 |
| Cumulative live birth per cycle start | 50.6% (157/310) | 51.5% (159/309) | Similar at six months despite 43 more transfers in the recombinant-FSH arm |
This was randomized and assessor-blinded, but treatment was open-label and the design asked noninferiority in selected high responders under a specific ICSI and transfer protocol.
The lower OHSS rate is clinically useful within this trial, but it is protocol-dependent. Trigger choice, cryopreservation rules, monitoring, dose adjustment, embryo-transfer strategy, and the AMH-selected population all limit transfer to another clinic or patient.
MEGASET-HR · outcome funnel
Randomized assessor-blinded noninferiority trial
Witz CA et al. Fertility and Sterility. 2020;114(2):321-330. doi:10.1016/j.fertnstert.2020.03.013. PMID: 32416978.
In 620 predicted high responders, HP-hMG was noninferior to recombinant FSH for ongoing pregnancy after fresh transfer; OHSS and early pregnancy loss were lower, while six-month cumulative live birth was 50.6% versus 51.5%.
- Participants / model
- 620 ovulatory women aged 21 to 35 with AMH at least 5 ng/mL; 619 treated
- Treatment
- HP-hMG or recombinant FSH in a GnRH-antagonist ICSI cycle with fresh single-blastocyst transfer or freeze-all for excessive response and frozen transfer follow-up
- Follow-up
- One stimulation cycle with eligible frozen transfers within six months
- Study design
- Randomized open-label, assessor-blinded, parallel-group noninferiority trial
- Funding
- Ferring Pharmaceuticals; sponsor-affiliated authors
The primary question was noninferiority, not superiority. Results depend on a selected high-responder population and protocol, and the recombinant-FSH group underwent 43 more transfers.
Read the original sourceNCT02554279 · protocol record
Clinical trial registry
ClinicalTrials.gov. NCT02554279. Menopur in GnRH Antagonist Single Embryo Transfer High Responder Trial.
Defines the two treatment arms, selected high-responder population, stimulation and transfer protocol, outcome time frames, and registry denominators.
- Participants / model
- Predicted high-responder women undergoing ICSI
- Treatment
- HP-hMG versus recombinant FSH
- Follow-up
- Stimulation plus fresh and protocol-eligible frozen transfer follow-up
- Study design
- Randomized active-comparator noninferiority registry record
- Funding
- Ferring Pharmaceuticals
A registry record supports protocol and outcome definitions; the peer-reviewed publication supplies the comparative interpretation.
Read the original sourceDid a Chinese randomized trial answer the same high-responder question?
The Chongqing trial tested a different population: 127 normogonadotropic women age 35 or older in their first IVF or ICSI cycle under a long GnRH-agonist protocol. Recombinant FSH produced more leading follicles and oocytes. The live-birth odds ratio numerically favored highly purified hMG at 1.9, but its 95% confidence interval of 0.9 to 3.9 included no difference.
The authors reported noninferiority and said superiority in live birth could not be concluded. The trial used a Chinese, older reproductive-age population and a different downregulation protocol. Its class-level HP-hMG result does not establish Menopur superiority in MEGASET-HR's younger high-responder population.
Chongqing RCT · age 35 and older
Prospective randomized controlled trial
Ye H et al. Gynecological Endocrinology. 2012;28(7):540-544. doi:10.3109/09513590.2011.650742. PMID: 22390186.
In 127 Chinese women age 35 or older, recombinant FSH produced more leading follicles and oocytes; live birth numerically favored HP-hMG but the confidence interval crossed no difference, so superiority was not shown.
- Participants / model
- 127 consecutive normogonadotropic infertile women age 35 or older at a Chongqing center, first IVF or ICSI cycle
- Treatment
- HP-hMG, n=63, versus recombinant FSH, n=64, in a long GnRH-agonist protocol
- Follow-up
- One treatment cycle
- Study design
- Prospective randomized controlled single-center trial
This is a small Chinese class-level HP-hMG study using a different age group and protocol. The abstract does not report product branding, allocation details, or complete adverse-event data.
Read the original sourceWhat does the 1985 male gonadotropin study establish?
Twenty-one men with hypogonadotropic hypogonadism first received hCG. Normal sperm counts developed in all six whose hypogonadism began after puberty but only one of 15 whose condition began before puberty. The remaining 14 men with prepubertal-onset disease then received historical human menopausal gonadotropin in addition to hCG.
With the combination, sperm count normalized in five of seven men without prior cryptorchidism and one of seven with it. This was a small staged, uncontrolled physiologic replacement study. hMG's contribution cannot be separated from ongoing hCG, and the abstract does not establish current Menopur branding, route, or a modern regimen.
Finkel study · historical hCG plus hMG
Small uncontrolled staged clinical study
Finkel DM, Phillips JL, Snyder PJ. New England Journal of Medicine. 1985;313(11):651-655. doi:10.1056/NEJM198509123131102. PMID: 3927163.
After an hCG-only phase in 21 men, 14 prepubertal-onset nonresponders received historical hMG in addition to hCG; sperm counts normalized in five of seven without cryptorchidism and one of seven with it.
- Participants / model
- 21 men with hypogonadotropic hypogonadism; 14 prepubertal-onset nonresponders entered the combined hMG plus hCG stage
- Treatment
- Human chorionic gonadotropin first, then historical human menopausal gonadotropin added for selected nonresponders
- Follow-up
- Not reported in the public abstract
- Study design
- Small staged uncontrolled physiologic replacement study
- Funding
- US Public Health Service grant support listed in PubMed
The hMG effect cannot be separated from continued hCG. The abstract does not establish a current Menopur product, route, dose, or male indication.
Read the original sourceWhich risks can emerge during stimulation, after trigger, or after pregnancy begins?
Excess ovarian response can cause abnormal enlargement, torsion, and ovarian hyperstimulation syndrome. OHSS may progress rapidly and can include ascites, breathing problems, blood-volume changes, thromboembolism, kidney injury, and rare death. It can appear after treatment stops and may worsen if pregnancy occurs.
- During stimulation: ultrasound and sometimes estradiol track follicular response and excess response.
- After trigger: abdominal or pelvic pain, distension, nausea, vomiting, rapid weight change, or breathing difficulty can signal OHSS or torsion.
- After conception: ectopic pregnancy, miscarriage, and multifetal gestation remain distinct risks that stimulation response cannot rule out.
- Across the protocol: the current label says human drug-interaction studies have not been conducted, so absence of a listed interaction is not proof of no interaction.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceWhy is menotropins one step in an ART protocol?
FSH activity recruits and develops ovarian follicles. LH activity supports steroid production and maturation in the ovarian environment. Clinicians adjust stimulation from the measured response, then use a separate trigger when follicles are ready. Retrieval, fertilization, embryo development, implantation, and birth still have to occur afterward.
The label reports an FSH elimination half-life of about 11 to 13 hours after repeated subcutaneous or intramuscular administration in pituitary-suppressed healthy premenopausal women. That is FSH-activity pharmacokinetics in a defined setting, not one half-life for every component, route, sex, or hMG product.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceWhich records apply to each fertility use?
The current Menopur label covers US product composition, female ART indication, monitoring, and safety. MEGASET-HR studied selected high responders. The Chongqing trial studied class-level HP-hMG in a smaller Chinese older-age population. The 1985 report studied historical male hMG only in combination with hCG.
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceMEGASET-HR · outcome funnel
Randomized assessor-blinded noninferiority trial
Witz CA et al. Fertility and Sterility. 2020;114(2):321-330. doi:10.1016/j.fertnstert.2020.03.013. PMID: 32416978.
In 620 predicted high responders, HP-hMG was noninferior to recombinant FSH for ongoing pregnancy after fresh transfer; OHSS and early pregnancy loss were lower, while six-month cumulative live birth was 50.6% versus 51.5%.
- Participants / model
- 620 ovulatory women aged 21 to 35 with AMH at least 5 ng/mL; 619 treated
- Treatment
- HP-hMG or recombinant FSH in a GnRH-antagonist ICSI cycle with fresh single-blastocyst transfer or freeze-all for excessive response and frozen transfer follow-up
- Follow-up
- One stimulation cycle with eligible frozen transfers within six months
- Study design
- Randomized open-label, assessor-blinded, parallel-group noninferiority trial
- Funding
- Ferring Pharmaceuticals; sponsor-affiliated authors
The primary question was noninferiority, not superiority. Results depend on a selected high-responder population and protocol, and the recombinant-FSH group underwent 43 more transfers.
Read the original sourceNCT02554279 · protocol record
Clinical trial registry
ClinicalTrials.gov. NCT02554279. Menopur in GnRH Antagonist Single Embryo Transfer High Responder Trial.
Defines the two treatment arms, selected high-responder population, stimulation and transfer protocol, outcome time frames, and registry denominators.
- Participants / model
- Predicted high-responder women undergoing ICSI
- Treatment
- HP-hMG versus recombinant FSH
- Follow-up
- Stimulation plus fresh and protocol-eligible frozen transfer follow-up
- Study design
- Randomized active-comparator noninferiority registry record
- Funding
- Ferring Pharmaceuticals
A registry record supports protocol and outcome definitions; the peer-reviewed publication supplies the comparative interpretation.
Read the original sourceChongqing RCT · age 35 and older
Prospective randomized controlled trial
Ye H et al. Gynecological Endocrinology. 2012;28(7):540-544. doi:10.3109/09513590.2011.650742. PMID: 22390186.
In 127 Chinese women age 35 or older, recombinant FSH produced more leading follicles and oocytes; live birth numerically favored HP-hMG but the confidence interval crossed no difference, so superiority was not shown.
- Participants / model
- 127 consecutive normogonadotropic infertile women age 35 or older at a Chongqing center, first IVF or ICSI cycle
- Treatment
- HP-hMG, n=63, versus recombinant FSH, n=64, in a long GnRH-agonist protocol
- Follow-up
- One treatment cycle
- Study design
- Prospective randomized controlled single-center trial
This is a small Chinese class-level HP-hMG study using a different age group and protocol. The abstract does not report product branding, allocation details, or complete adverse-event data.
Read the original sourceFinkel study · historical hCG plus hMG
Small uncontrolled staged clinical study
Finkel DM, Phillips JL, Snyder PJ. New England Journal of Medicine. 1985;313(11):651-655. doi:10.1056/NEJM198509123131102. PMID: 3927163.
After an hCG-only phase in 21 men, 14 prepubertal-onset nonresponders received historical hMG in addition to hCG; sperm counts normalized in five of seven without cryptorchidism and one of seven with it.
- Participants / model
- 21 men with hypogonadotropic hypogonadism; 14 prepubertal-onset nonresponders entered the combined hMG plus hCG stage
- Treatment
- Human chorionic gonadotropin first, then historical human menopausal gonadotropin added for selected nonresponders
- Follow-up
- Not reported in the public abstract
- Study design
- Small staged uncontrolled physiologic replacement study
- Funding
- US Public Health Service grant support listed in PubMed
The hMG effect cannot be separated from continued hCG. The abstract does not establish a current Menopur product, route, dose, or male indication.
Read the original sourceFDA SRS · menotropins identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Menotropins, UNII 5Y9QQM372Q.
Provides the official substance name, aliases, CAS, and UNII for the biologic mixture.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
Substance registration does not establish product approval, interchangeability, clinical efficacy, or a single molecular formula.
Read the original sourceStudies and sources
Menopur label · female ART
FDA prescribing information
Ferring Pharmaceuticals. MENOPUR (menotropins for injection) prescribing information.
Defines the urinary FSH and LH activity product, current ovulatory-women ART indication, stimulation and trigger sequence, pivotal 373-woman trial, FSH PK, monitoring, contraindications, OHSS and pregnancy risks, and absence of human interaction studies.
- Participants / model
- Ovulatory women undergoing an assisted-reproductive-technology cycle
- Treatment
- Reconstituted subcutaneous Menopur within a specialist-directed ovarian-stimulation protocol
- Follow-up
- One monitored stimulation cycle in the pivotal comparative study
- Study design
- Regulatory label summarizing an open-label randomized multinational active-comparator trial
- Funding
- Sponsor regulatory program
The US label does not contain a male indication and does not make all hMG products interchangeable.
Read the original sourceMEGASET-HR · outcome funnel
Randomized assessor-blinded noninferiority trial
Witz CA et al. Fertility and Sterility. 2020;114(2):321-330. doi:10.1016/j.fertnstert.2020.03.013. PMID: 32416978.
In 620 predicted high responders, HP-hMG was noninferior to recombinant FSH for ongoing pregnancy after fresh transfer; OHSS and early pregnancy loss were lower, while six-month cumulative live birth was 50.6% versus 51.5%.
- Participants / model
- 620 ovulatory women aged 21 to 35 with AMH at least 5 ng/mL; 619 treated
- Treatment
- HP-hMG or recombinant FSH in a GnRH-antagonist ICSI cycle with fresh single-blastocyst transfer or freeze-all for excessive response and frozen transfer follow-up
- Follow-up
- One stimulation cycle with eligible frozen transfers within six months
- Study design
- Randomized open-label, assessor-blinded, parallel-group noninferiority trial
- Funding
- Ferring Pharmaceuticals; sponsor-affiliated authors
The primary question was noninferiority, not superiority. Results depend on a selected high-responder population and protocol, and the recombinant-FSH group underwent 43 more transfers.
Read the original sourceNCT02554279 · protocol record
Clinical trial registry
ClinicalTrials.gov. NCT02554279. Menopur in GnRH Antagonist Single Embryo Transfer High Responder Trial.
Defines the two treatment arms, selected high-responder population, stimulation and transfer protocol, outcome time frames, and registry denominators.
- Participants / model
- Predicted high-responder women undergoing ICSI
- Treatment
- HP-hMG versus recombinant FSH
- Follow-up
- Stimulation plus fresh and protocol-eligible frozen transfer follow-up
- Study design
- Randomized active-comparator noninferiority registry record
- Funding
- Ferring Pharmaceuticals
A registry record supports protocol and outcome definitions; the peer-reviewed publication supplies the comparative interpretation.
Read the original sourceChongqing RCT · age 35 and older
Prospective randomized controlled trial
Ye H et al. Gynecological Endocrinology. 2012;28(7):540-544. doi:10.3109/09513590.2011.650742. PMID: 22390186.
In 127 Chinese women age 35 or older, recombinant FSH produced more leading follicles and oocytes; live birth numerically favored HP-hMG but the confidence interval crossed no difference, so superiority was not shown.
- Participants / model
- 127 consecutive normogonadotropic infertile women age 35 or older at a Chongqing center, first IVF or ICSI cycle
- Treatment
- HP-hMG, n=63, versus recombinant FSH, n=64, in a long GnRH-agonist protocol
- Follow-up
- One treatment cycle
- Study design
- Prospective randomized controlled single-center trial
This is a small Chinese class-level HP-hMG study using a different age group and protocol. The abstract does not report product branding, allocation details, or complete adverse-event data.
Read the original sourceFinkel study · historical hCG plus hMG
Small uncontrolled staged clinical study
Finkel DM, Phillips JL, Snyder PJ. New England Journal of Medicine. 1985;313(11):651-655. doi:10.1056/NEJM198509123131102. PMID: 3927163.
After an hCG-only phase in 21 men, 14 prepubertal-onset nonresponders received historical hMG in addition to hCG; sperm counts normalized in five of seven without cryptorchidism and one of seven with it.
- Participants / model
- 21 men with hypogonadotropic hypogonadism; 14 prepubertal-onset nonresponders entered the combined hMG plus hCG stage
- Treatment
- Human chorionic gonadotropin first, then historical human menopausal gonadotropin added for selected nonresponders
- Follow-up
- Not reported in the public abstract
- Study design
- Small staged uncontrolled physiologic replacement study
- Funding
- US Public Health Service grant support listed in PubMed
The hMG effect cannot be separated from continued hCG. The abstract does not establish a current Menopur product, route, dose, or male indication.
Read the original sourceFDA SRS · menotropins identity
Official substance identity record
US Food and Drug Administration Substance Registration System. Menotropins, UNII 5Y9QQM372Q.
Provides the official substance name, aliases, CAS, and UNII for the biologic mixture.
- Participants / model
- Not applicable
- Treatment
- Not applicable
- Study design
- Regulatory substance registry
Substance registration does not establish product approval, interchangeability, clinical efficacy, or a single molecular formula.
Read the original sourceWhy is Menotropins in S tier?
The S tier reflects an approved fertility medicine with controlled ART trials and clinically meaningful pregnancy and live-birth outcomes. It covers the labeled female ART product and supervised protocols. It does not make every urinary hMG product interchangeable, prove superiority over recombinant FSH across populations, or establish current male, libido, or hormone-optimization use.
read Menotropins in the reptides guide, chapter 18: 9 pages, free to read.