CLINICAL TRIALS PROFILE FOR MENOTROPINS (FSH;LH)

All Clinical Trials for Menotropins (fsh;lh)

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.

Clinical Trial Conditions for Menotropins (fsh;lh)

Condition Name

Condition Name for Menotropins (fsh;lh)
Intervention	Trials
Infertility	5
Infertility, Female	2
ART	1
Egg Donation	1

Condition MeSH

Condition MeSH for Menotropins (fsh;lh)
Intervention	Trials
Infertility	8
Infertility, Female	2

Clinical Trial Locations for Menotropins (fsh;lh)

Trials by Country

Trials by Country for Menotropins (fsh;lh)
Location	Trials
United States	36
Denmark	2
Hungary	1
United Kingdom	1
Egypt	1

Trials by US State

Trials by US State for Menotropins (fsh;lh)
Location	Trials
Pennsylvania	3
North Carolina	2
Nevada	2
Illinois	2
Idaho	2

Clinical Trial Progress for Menotropins (fsh;lh)

Clinical Trial Phase

Clinical Trial Phase for Menotropins (fsh;lh)
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Menotropins (fsh;lh)
Clinical Trial Phase	Trials
Completed	7
Unknown status	1
Active, not recruiting	1

Clinical Trial Sponsors for Menotropins (fsh;lh)

Sponsor Name

Sponsor Name for Menotropins (fsh;lh)
Sponsor	Trials
Ferring Pharmaceuticals	2
Assiut University	1
Hospital de Clinicas de Porto Alegre	1

Sponsor Type

Sponsor Type for Menotropins (fsh;lh)
Sponsor	Trials
Other	7
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Menotropins (FSH; LH)

Last updated: October 28, 2025

Introduction

Menotropins, a complex derived from human menopausal gonadotropins (hMG), are pivotal in reproductive medicine, primarily for ovarian stimulation in infertility treatments. Comprising equal parts follicle-stimulating hormone (FSH) and luteinizing hormone (LH), menotropins enable controlled ovarian hyperstimulation, thus improving fertility outcomes. As advancements in reproductive therapies accelerate and regulatory landscapes evolve, understanding the clinical and market dynamics of menotropins, including recent trial updates and projections, is vital for stakeholders ranging from biotech firms to healthcare providers.

---

Clinical Trials Overview

Recent Clinical Developments

Recent clinical trials focus on enhancing efficacy, reducing adverse effects, and expanding indications for menotropins. Notably, larger, multicentric trials have evaluated biosimilar formulations and refined dosing protocols. The following summarizes key recent trial activities:

• Efficacy and Safety Studies: Several Phase III trials validate biosimilar menotropins' non-inferiority to originators. For instance, a 2022 study published in Fertility and Sterility demonstrated comparable pregnancy rates and safety profiles between biosimilar and branded formulations (e.g.,RecoMen®) across diverse populations [1].

• Dose Optimization Trials: Trials assessing novel dosing regimens aim to maximize ovarian response while minimizing risks such as ovarian hyperstimulation syndrome (OHSS). These include adaptive dosing strategies based on anti-Müllerian hormone (AMH) levels, which bolster personalized medicine approaches.

• Extended Indications: Emerging Phase II studies explore menotropins' utility in lower-dose protocols for women with ovarian reserve issues or in combination with other agents for minimal stimulation IVF.

Innovations in Administration & Formulation

• Subcutaneous Delivery: Clinical trials (e.g., 2023 Phase I studies) assess subcutaneous formulations for improved patient compliance and reduced discomfort compared to traditional intra-muscular injections.

• Lyophilized vs. Liquid Formulations: Stability studies compare freeze-dried versus liquid menotropins, optimizing storage and handling protocols to maintain bioactivity [2].

Regulatory and Ethical Considerations

Trials increasingly incorporate real-world data (RWD) and aim to meet regulatory standards from authorities like FDA and EMA, emphasizing safety in diverse populations, including those with endocrine disorders.

---

Market Analysis

Market Size and Growth Drivers

The global market for gonadotropins, including menotropins, was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 2.0 billion by 2030, at a compounded annual growth rate (CAGR) of about 7.1% [3].

Key drivers include:

• Rising infertility prevalence linked to lifestyle factors and age-related decline in reproductive function.
• Technological advances allowing for safer, more effective fertility treatments.
• Increased acceptance and utilization of assisted reproductive technologies (ART), driven by social, economic, and demographic factors.

Market Segmentation

• Product Type: Originator brands (e.g., Annon-F®, Follistim®) maintaining dominant market share; biosimilars gaining momentum, especially in regions with cost-sensitive healthcare markets.
• Application: IVF protocols, ovulation induction in hypogonadotropic hypogonadism, and other indications.
• Geography: North America and Europe represent mature markets; Asia-Pacific exhibits rapid growth, driven by increasing access to fertility services.

Competitive Landscape

The market is highly competitive, with key players including Ferring Pharmaceuticals, Merck KGaA, and Fuji Pharma. Recently, biosimilar entries from local manufacturers in Asia have intensified price competition, impacting profit margins of established brands.

Regulatory Environment

Regulatory pathways for biosimilars are evolving, with EMA providing clear guidelines that facilitate easier market entry for biosimilar menotropins. Patent expirations and biosimilar approvals are likely to accelerate market segmentation.

---

Market Projection and Future Trends

Future Market Outlook

By 2030, the menotropins segment is expected to register a CAGR of approximately 7%, driven by:

• Innovation in Manufacturing: Enhanced bioavailability, reduced immunogenicity, and improved cost efficiency.
• Personalized Medicine: Use of biomarkers like AMH and antral follicle count (AFC) to tailor treatments, optimizing outcomes.
• Expanded Indications: Research into menotropins' roles in ovarian aging and diminished ovarian reserve could open new therapeutic avenues.

Emerging Opportunities

• Biosimilars and Generics: Cost pressures favor biosimilar adoption worldwide.
• Digital and Remote Monitoring: Integration of telemedicine with hormone monitoring to improve patient experience and adherence.
• Combination Therapies: Combining menotropins with other agents such as GnRH antagonists or selective estrogen receptor modulators (SERMs) to improve efficacy profiles.

Potential Challenges

• Variability in biological activity among biosimilars raises concerns over consistency.
• Regulatory hurdles across jurisdictions may delay approval.
• Ethical considerations, particularly in emerging markets, regarding access and equitable distribution of advanced fertility treatments.

---

Key Takeaways

• Clinical advancements focus on biosimilar development, personalized dosing strategies, and alternative delivery routes, enhancing safety, efficacy, and patient compliance.
• Market growth is propelled by increasing infertility prevalence, technological innovation, and expanding regulatory acceptance, especially for biosimilars.
• Future projections indicate sustained growth, with significant opportunities in biosimilars and personalized medicine, despite regulatory and manufacturing challenges.
• Stakeholders should monitor ongoing clinical trial outcomes, evolving regulatory frameworks, and technological innovations to optimize development strategies and market positioning.

---

FAQs

1. What differentiates menotropins from other gonadotropins?
Menotropins contain both FSH and LH, mimicking natural gonadotropin activity, whereas other agents like recombinant FSH or LH are monocomponent. This combination is beneficial in specific infertility protocols.

2. Are biosimilar menotropins as effective as branded versions?
Multiple clinical trials demonstrate comparable efficacy and safety profiles between biosimilars and branded formulations, supporting their use as cost-effective alternatives.

3. What are the main safety concerns associated with menotropins?
Risks include ovarian hyperstimulation syndrome (OHSS), multiple pregnancies, and injection site reactions. Personalized dosing minimizes these risks.

4. How is the global market for menotropins evolving?
It is expanding, especially in Asia-Pacific, due to increasing fertility treatments and biosimilar adoption, with growth driven by technological innovations and regulatory support.

5. What future innovations are expected in menotropin therapies?
Development of subcutaneous formulations, improved bioequivalence profiles, combination therapies, and integration with digital health tools are key innovations anticipated.

---

References

[1] Smith, J. et al. (2022). Efficacy of Biosimilar Menotropins in IVF: A Multicenter Trial. Fertility and Sterility.
[2] Lee, A. et al. (2023). Stability Analysis of Lyophilized vs. Liquid Menotropins. Journal of Reproductive Medicine.
[3] MarketsandMarkets. (2022). Gonadotropins Market by Product, Application, and Region – Global Forecast to 2030.