CLINICAL TRIALS PROFILE FOR MENOTROPINS

All Clinical Trials for menotropins

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01312766 ↗	Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients	Completed	IBSA Institut Biochimique SA	Phase 3	2011-02-01	The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
NCT01569945 ↗	Hormonal Stimulation in IUI Treatment: Is Clomifen Combined With Ethinyl Estradiol Better, Worse or Equal to Menopur	Completed	University Hospital, Gasthuisberg	N/A	2004-09-01	What is the best medication for hormonal stimulation in cycles with high intra-uterine insemination: tablets of Clomifen (5 days) followed by tablets of Ethinyl Estradiol (5 days) or daily injections with Human Menopausal Gonadotropin (Menopur)?
NCT02069808 ↗	Efficacy of Recombinant FSH/GnRH Antagonist Protocol With and Without LH Adjunct for Egg Bank Donation	Completed	Michigan Reproductive Medicine	Phase 4	2014-04-01	Disprove the null hypothesis as follows: Among the investigator's egg bank donors undergoing ovulation induction with recombinant FSH medication per treatment protocol outlined below, use of adjunctive LH activity medication Menopur ™ , will result in the same number of mature oocytes recovered and cryopreserved as from egg donors not treated with Menopur™. Objectives: Compare efficacy of recombinant FSH (Follistim ™) with and without adjunct LH activity medication Menopur ™ for our volunteer egg bank donors. Efficacy defined as: 1. #Days of ovarian stimulation to GnRH agonist trigger. 2. Peak serum estradiol level on day of GnRH agonist trigger. 3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger. 4. Number of mature oocytes recovered and cryopreserved. Study type: Randomized prospective clinical trial. Patient selection: Voluntary egg donors who have satisfied all screening criteria for FDA and the Michigan Egg Bank: Age range 18-to 39 years. BMI 18 to 25. Resting antral follicle count of 16 or greater. Cycle day 3 FSH 2.0 ng/ml. Study design: Two groups- Group A- Recombinant FSH Follistim only; Group B- Recombinant FSH Follistim and adjunct Menopur. Both groups will use GnRH agonist trigger 36 hours prior to egg retrieval. Random number generator with patients assigned basd on odd or even numbers. Number of subjects: 25 in each group. Total of 50 subjects. This takes into account possible cycle cancellation for poor ovarian response or patient elective withdrawal to result in at least 20 subjects in each group completing the study. Primary measure of outcome: number of mature oocytes recovered and cryopreserved. Secondary measures of outcome: 1. #Days of ovarian stimulation to GnRH agonist trigger. 2. Peak serum estradiol level on day of GnRH agonist trigger. 3. Number of follicles >15 mm average diameter on day of GnRH agonist trigger.
NCT02418533 ↗	Mono-menotropins Versus rFSH Protocol on Embryo Quality	Completed	Main Line Fertility Center	N/A	2015-03-01	This study is for couples pursuing in vitro fertilization (IVF) with preimplantation genetic screening (PGS) of embryos to achieve pregnancy. The objective of this clinical trial is to study the effect of mono-menotropins for COS versus recombinant follicle stimulating hormone (rFSH) on cleavage-stage and blastocyst embryo quality after IVF. Embryo quality parameters include conventional embryo grade, early embryo viability assessment (Eeva) time-lapse parameters, and chromosomal aneuploidy rates after PGS. This pilot study is expected to significantly contribute to optimization of treatment regimens and stimulation protocols to optimize embryo quality.
NCT02554279 ↗	MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population	Completed	Ferring Pharmaceuticals	Phase 4	2015-08-31	The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment.
NCT02992808 ↗	Androgenic Profile Following Controlled Ovarian Stimulation	Unknown status	Sheba Medical Center	Phase 4	2016-12-01	In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.

Clinical Trial Conditions for menotropins

Condition Name

Condition Name for menotropins
Intervention	Trials
Infertility	5
Infertility, Female	2
ART	1
Egg Donation	1

Condition MeSH

Condition MeSH for menotropins
Intervention	Trials
Infertility	8
Infertility, Female	2

Clinical Trial Locations for menotropins

Trials by Country

Trials by Country for menotropins
Location	Trials
United States	36
Denmark	2
United Kingdom	1
Egypt	1
France	1

Trials by US State

Trials by US State for menotropins
Location	Trials
Pennsylvania	3
Idaho	2
Florida	2
California	2
Arizona	2

Clinical Trial Progress for menotropins

Clinical Trial Phase

Clinical Trial Phase for menotropins
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for menotropins
Clinical Trial Phase	Trials
Completed	7
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for menotropins

Sponsor Name

Sponsor Name for menotropins
Sponsor	Trials
Ferring Pharmaceuticals	2
Kuban State Medical University	1
IBSA Institut Biochimique SA	1

Sponsor Type

Sponsor Type for menotropins
Sponsor	Trials
Other	7
Industry	3

Menotropins: Clinical Trials Update, Market Analysis and 10-Year Projection

Last updated: April 28, 2026

What’s happening in menotropins clinical development?

Menotropins (gonadotropin therapy containing FSH and LH activity) are marketed in multiple regions for infertility indications, most commonly controlled ovarian stimulation (COS) and assisted reproductive technology (ART). Public, trial-level updates are fragmented across jurisdictions and brands, and for many products the active ingredient is long established. As a result, the clinical landscape is dominated by: (1) ongoing comparative and safety studies tied to specific formulations and delivery systems, and (2) post-authorization pharmacovigilance and registries rather than late-stage, label-expansion programs.

Trial pattern by study type (typical for established gonadotropins)

• Randomized trials: Often compare dosing regimens and outcome endpoints in COS/ART cycles, focusing on ovulation response, number of mature follicles, pregnancy rates, and cycle cancellation rate.
• Observational studies/registries: Track pregnancy outcomes, adverse events, and real-world dosing patterns across age groups and baseline risk (e.g., PCOS cohorts).
• Safety-focused studies: Focus on ovarian hyperstimulation syndrome (OHSS) incidence, immunogenicity signals, and adverse event profiles.

Operational implications for development teams

• Labeling risk is lower but incremental differentiation is harder. For established menotropins, regulators typically expect robust demonstration of clinical performance consistency (dose-response, cycle outcomes) and safety.
• Endpoint selection is constrained. Most studies must align with ART-associated endpoints (mature oocytes, clinical pregnancy rates, OHSS).
• Cost of evidence is high while novelty is low. Many programs focus on formulation/process improvements that still require clinical bridging.

Where does the market sit today for menotropins?

Menotropins sit within the broader global gonadotropins market, which includes recombinant FSH products and LH-containing recombinant or urinary options. In many markets, recombinant FSH has displaced parts of urinary supply due to perceived consistency, but urinary menotropins still retain share because of cost, availability, and clinician familiarity.

Current demand drivers

• Rising ART utilization in high-income markets and growing adoption in emerging markets.
• Delayed childbearing and rising infertility prevalence.
• Guideline-driven gonadotropin use for COS protocols in IVF and ICSI cycles.
• Price sensitivity and payer formularies that favor established therapies.

Competitive landscape

The competitive set typically includes:

• Recombinant FSH products (often preferred for cycle predictability).
• Urinary gonadotropins (menotropins and urofollitropin) used where access and pricing dominate choice.
• Biosimilar recombinant FSH offerings where those products are approved and reimbursed.

Commercial reality

• Menotropins are not usually positioned as premium differentiation.
• They win on access and formulary inclusion, especially where payer policies and clinic procurement favor established, widely available gonadotropin options.

How fast is the segment likely to grow, and what forces will move it?

Growth is driven by fertility clinic activity, ART cycle volumes, and uptake in underpenetrated geographies. Offsetting forces include:

• Shift toward recombinant FSH in many formularies.
• Biosimilar substitution inside recombinant classes, which can pressure clinician willingness to use urinary products unless pricing is favorable.
• Supply-chain volatility for urinary-derived products, which can produce temporary shortages and price spikes.

10-Year market projection: base, bull, bear

Because public, consolidated market sizing for “menotropins-only” is rarely disclosed in the same way as broad gonadotropins categories, the projection below is structured to support investment and R&D planning using category dynamics typical for urinary gonadotropins within the IVF drug stack.

Key assumptions used for projection framework

• Menotropins keep share in cost-sensitive segments and in geographies with slower recombinant penetration.
• Recombinant and biosimilar FSH continue to compress share in higher-income markets.
• Overall fertility drug spend grows with ART volume.

Projection (global menotropins market value)

Scenario	CAGR (2025-2034)	2025 Market (Index = 100)	2034 Market (Index)
Bear	2.5%	100	131
Base	4.0%	100	149
Bull	6.0%	100	179

Interpretation for business planning

• Under the base case, menotropins grow but do not regain lost share versus recombinant FSH. Value expansion comes mainly from ART growth and pricing normalization rather than substitution reversal.
• Under the bear case, substitution and biosimilar pressure dominate in major reimbursement markets, limiting value growth.
• Under the bull case, supply stability and payer inclusion expand, while ART growth outpaces substitution.

What clinical evidence matters most for market access?

For menotropins, value is tied to cycle performance and safety outcomes rather than mechanistic novelty.

Evidence categories that influence uptake

• COS/ART cycle endpoints
  • Mature follicle yield and oocyte maturity
  • Clinical pregnancy rate per started cycle
  • Ongoing pregnancy and implantation rates (where available)
  • Cycle cancellation rate
• Safety endpoints
  • OHSS incidence and severity distribution
  • Adverse event frequency by system organ class
  • Serious adverse event rates per exposure

Regulatory positioning

• Products usually seek outcomes alignment with established ART standards.
• Post-authorization safety and pharmacovigilance often carry more weight than new efficacy demonstrations for stable active ingredients.

Where are the highest-value commercial opportunities?

Menotropins opportunity clusters typically concentrate in:

• Second-line formularies where reimbursement favors established urinary products.
• Regions with lower recombinant coverage and higher procurement sensitivity.
• Clinic networks that standardize COS protocols using urinary gonadotropins.

R&D implications

Programs that maximize commercial relevance typically focus on:

• Formulation/process consistency that reduces lot-to-lot variability concerns.
• Cycle management protocols that improve OHSS mitigation and reduce cancellations.
• Value-based studies that map outcomes to payer decision-making.

Key risks and what they mean for planning

• Recombinant migration risk: Continued substitution can reduce growth rate and compress pricing.
• Supply risk: Urinary supply constraints can disrupt continuity of treatment and erode clinic trust.
• Pricing pressure: Biosimilar penetration in adjacent categories can pull down overall payer willingness to pay.
• Clinical evidence expectations: Even for established actives, regulators and payers demand clean, clinically interpretable evidence for any change that affects product performance.

Key Takeaways

• Menotropins development is dominated by incremental, protocol-linked clinical work and real-world safety monitoring, not brand-new mechanism science.
• Demand remains supported by ART growth and payer price sensitivity, while substitution pressure from recombinant/biosimilar FSH persists.
• The global menotropins market projection points to low-to-mid single digit value growth through 2034: Bear 2.5%, Base 4.0%, Bull 6.0% CAGR, with 2034 market index outcomes of 131, 149, 179 vs 2025.

FAQs

1) What is menotropins used for in clinical practice?
Menotropins are used for ovarian stimulation in infertility treatment, including COS for IVF/ART protocols.

2) What most affects clinician choice between menotropins and recombinant FSH?
Pricing and reimbursement, perceived cycle predictability, product availability, and protocol standardization within fertility clinics.

3) What safety endpoint is most monitored for menotropins in trials?
OHSS (ovarian hyperstimulation syndrome), including incidence and severity.

4) Do menotropins development programs usually seek major label expansions?
For established active ingredients, programs typically pursue evidence that supports stable use, safety, and performance with specific formulations or regimens rather than major new indications.

5) How should investors interpret steady growth projections for an established gonadotropin?
Growth is primarily driven by ART volume and access dynamics, offset by recombinant and biosimilar substitution within fertility drug formularies.

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References

[1] FDA. (n.d.). Gonadotropins (fertility) drug safety information and labeling resources. U.S. Food and Drug Administration.
[2] EMA. (n.d.). European public assessment reports and product information for gonadotropin medicines. European Medicines Agency.
[3] Practice Committee of the American Society for Reproductive Medicine. (2018). Controlled ovarian hyperstimulation: guidelines and clinical considerations. Fertility and Sterility.