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 <10 mIU/ml. AMH >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
Active, not recruiting	1
Not yet 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, Market Analysis, and Projections

Introduction to Menotropins

Menotropins, also known as menopausal gonadotropin, are a combination of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) derived from the urine of post-menopausal women. These hormones are crucial in stimulating follicle development in women and spermatogenesis in men, making them a key component in fertility treatments, including in vitro fertilization (IVF) and other assisted reproductive technologies (ART)[3].

Clinical Trials Update

MEGASET-HR Study

One of the significant clinical trials involving menotropins is the MEGASET-HR study conducted by Ferring Pharmaceuticals. This non-inferiority trial compared Menopur (menotropins for injection) with recombinant FSH (rFSH) in a predicted high responder population.

• Primary Endpoint: The study demonstrated that Menopur-treated patients achieved a 35.5% ongoing pregnancy rate (OPR) per cycle start after fresh embryo transfer, compared to 30.7% for rFSH-treated patients[1].
• Secondary Endpoints: The trial also showed that cumulative live birth rates were similar between the Menopur and rFSH groups. Additionally, early pregnancy loss rates were lower in the Menopur treatment group for both fresh and frozen embryo transfers. Patients in the Menopur group reported fewer treatment-emergent adverse events (TEAEs) and a lower incidence of ovarian hyperstimulation syndrome (OHSS)[1].

Other Clinical Trials

Another clinical trial protocol, also comparing Menopur with recombinant FSH (Gonal-f), was conducted to evaluate the efficacy and safety of these treatments in women undergoing controlled ovarian stimulation (COS) following a gonadotropin-releasing hormone (GnRH) antagonist protocol.

• Primary Objective: The trial aimed to demonstrate the non-inferiority of Menopur versus Gonal-f in terms of ongoing pregnancy rate. The study involved approximately 600 subjects randomized to receive either Menopur or Gonal-f, with the primary endpoint being the ongoing pregnancy rate at 10-11 weeks gestation[4].

Market Analysis

Global Market Size and Growth

The global menotropin market is experiencing significant growth driven by several key factors:

• Increasing Infertility Rates: The rise in infertility rates globally, particularly due to delayed childbearing and lifestyle changes, is a major driver. This trend is expected to continue, increasing the demand for menotropin therapies[2][3].
• Advancements in ART: Technological innovations in ART, such as better monitoring systems, embryo selection techniques, and genetic screening methods, are enhancing treatment efficacy and safety, thereby increasing the demand for menotropins[2].
• Regional Growth: The Asia Pacific region is witnessing the fastest growth due to rising infertility rates, increasing adoption of advanced fertility treatments, and improving healthcare infrastructure. Countries like China and India are significant contributors to this growth[2].

Market Segmentation

The global menotropin market is segmented by region, with North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa being the key markets.

• North America: Held more than 40% of the global revenue in 2024 and is expected to grow at a CAGR of 2.7% from 2024 to 2031[2].
• Europe: Held around 30% of the global revenue in 2024 and is expected to grow at a CAGR of 4.5% from 2024 to 2031[2].
• Asia Pacific: Held around 23% of the global revenue in 2024 and is expected to grow at a CAGR of 8.0% from 2024 to 2031, making it the fastest-growing region[2].

Key Players and Market Share

The market is dominated by a few key players:

• Ferring Pharmaceuticals: Menopur (menotropins) is one of the leading drugs in the market[5].
• EMD Serono: Gonal-F (follitropin alfa) and Merck: Follistim (follitropin beta) are other major players, with these three drugs accounting for over 50% of the market share in 2018[5].

Market Projections

Growth Rate and Forecast

The global menotropin market is projected to grow at a compound annual growth rate (CAGR) of 6.00% from 2024 to 2031. The market size is expected to expand from USD xx million in 2024 to USD xx million by 2031[2].

Drivers of Growth

• Increasing Adoption of ART: The growing acceptance and accessibility of ART procedures are driving the demand for menotropins[2][3].
• Technological Innovations: Advances in ART technologies are improving treatment outcomes, which in turn is increasing the demand for menotropins[2].
• Rising Healthcare Expenditure: Growing healthcare expenditure and supportive regulatory frameworks are also contributing to market growth[2].

Challenges and Opportunities

Despite the positive growth projections, the menotropin market faces several challenges:

• High Cost of Treatment: The high cost of fertility treatments is a significant barrier to access[2].
• Regulatory Complexities: Navigating regulatory complexities and addressing ethical considerations are crucial for sustaining market growth[2].

However, opportunities exist in overcoming these barriers through affordability initiatives, technological advancements, and strategic collaborations.

Key Takeaways

• Clinical Efficacy: Menotropins have demonstrated non-inferiority to rFSH in clinical trials, with benefits including lower early pregnancy loss rates and fewer adverse events.
• Market Growth: The global menotropin market is growing at a CAGR of 6.00% from 2024 to 2031, driven by increasing infertility rates and advancements in ART.
• Regional Expansion: The Asia Pacific region is the fastest-growing market, driven by rising infertility rates and improving healthcare infrastructure.
• Challenges and Opportunities: Despite challenges such as high treatment costs and regulatory complexities, opportunities for growth exist through technological innovations and strategic collaborations.

FAQs

What are menotropins used for?

Menotropins are used to treat infertility issues in men and women by stimulating follicle development in women and spermatogenesis in men. They are also used in in-vitro fertilization (IVF) and other assisted reproductive technologies (ART)[3].

What is the primary endpoint in the MEGASET-HR study?

The primary endpoint in the MEGASET-HR study is the ongoing pregnancy rate (OPR) per cycle start after fresh embryo transfer, defined by the presence of at least one intrauterine pregnancy with a fetal heartbeat at 10-11 weeks gestation[1].

Which regions are driving the growth of the menotropin market?

The Asia Pacific region is experiencing the fastest growth, followed by North America and Europe. The growth in these regions is driven by rising infertility rates, increasing adoption of advanced fertility treatments, and improving healthcare infrastructure[2].

What are the key drivers of the menotropin market growth?

Key drivers include increasing infertility rates, advancements in ART, rising healthcare expenditure, and supportive regulatory frameworks. Technological innovations and growing awareness and acceptance of fertility treatments also contribute to market growth[2][3].

What are the challenges facing the menotropin market?

Challenges include the high cost of treatment, regulatory complexities, and ethical considerations. Overcoming these barriers through affordability initiatives, technological advancements, and strategic collaborations is crucial for sustaining growth[2].

Sources

1. Ferring Pharmaceuticals. New Clinical Data Published on Menopur® (menotropins for injection) in a Predicted High Responder Population. Retrieved from: https://ferringusa.com/?press=new-clinical-data-published-on-menopur-menotropins-for-injection-in-a-predicted-high-responder-population
2. Cognitive Market Research. Global Menotropin Market Report. Retrieved from: https://www.cognitivemarketresearch.com/menotropin-market-report
3. InsightSlice. Menotropin Market Share Growth, Size Value, Trends, Regional Outlook to 2032. Retrieved from: https://www.pharmiweb.com/press-release/2022-12-21/menotropin-market-share-growth-size-value-trends-regional-outlook-to-2032-insightslice
4. ClinicalTrials.gov. CLINICAL TRIAL PROTOCOL - A Randomized, Assessor-blind Trial Comparing MENOPUR® (menotropins for injection) and Recombinant FSH. Retrieved from: https://cdn.clinicaltrials.gov/large-docs/79/NCT02554279/Prot_001.pdf
5. European Pharmaceutical Review. Female infertility drug market to exhibit CAGR of 3.4 percent. Retrieved from: https://www.europeanpharmaceuticalreview.com/news/102575/female-infertility-drug-market-to-exhibit-cagr-of-3-4-percent/