CLINICAL TRIALS PROFILE FOR FOLLISTIM AQ

All Clinical Trials for Follistim Aq

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00802360 ↗	MENOPUR® Versus FOLLISTIM®	Completed	Ferring Pharmaceuticals	Phase 4	2008-12-01	To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
NCT00805935 ↗	Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	Completed	Ferring Pharmaceuticals	Phase 4	2009-01-01	This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
NCT00884221 ↗	MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer	Completed	Ferring Pharmaceuticals	Phase 3	2009-07-01	The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.
NCT00920361 ↗	Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.		2005-11-01	To evaluate dosage and administration method, efficacy and safety of Puregon and the relationship between background factors of patients and dose and administration method. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
NCT00920634 ↗	Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.		2007-07-01	The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
NCT01286051 ↗	Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles	Completed	Houston Fertility Institute	N/A	2011-01-01	Ovulation induction (OI) using gonadotropins is one of the most widely prescribed treatments of infertility. One common problem encountered while attempting OI using gonadotropins is premature ovulation. The purpose of this study is to examine the effect of a single injection of a medication, called ganirelix, to prevent premature ovulation. Patients will be divided into two groups. In the first group, gonadotropins will be used to stimulate the ovaries. In the second group gonadotropins will be used in addition to a single injection of ganirelix, a gonadotropin releasing hormone (GnRH) antagonist. Pregnancy rates will be compared between groups.
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.

Clinical Trial Conditions for Follistim Aq

Condition Name

Condition Name for Follistim Aq
Intervention	Trials
Infertility	5
Polycystic Ovarian Syndrome	1
Anovulation	1
Compare Pregnancy Rates Between FSH Stimulation and FSH and	1

Condition MeSH

Condition MeSH for Follistim Aq
Intervention	Trials
Infertility	6
Anovulation	1
Syndrome	1
Polycystic Ovary Syndrome	1

Clinical Trial Locations for Follistim Aq

Trials by Country

Trials by Country for Follistim Aq
Location	Trials
United States	15
Japan	12
Belgium	1
Poland	1
Turkey	1

Trials by US State

Trials by US State for Follistim Aq
Location	Trials
Texas	3
New York	2
Illinois	2
Florida	2
Colorado	2

Clinical Trial Progress for Follistim Aq

Clinical Trial Phase

Clinical Trial Phase for Follistim Aq
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Follistim Aq
Clinical Trial Phase	Trials
Completed	9
Enrolling by invitation	1

Clinical Trial Sponsors for Follistim Aq

Sponsor Name

Sponsor Name for Follistim Aq
Sponsor	Trials
Ferring Pharmaceuticals	5
Merck Sharp & Dohme Corp.	2
Houston Fertility Institute	1

Sponsor Type

Sponsor Type for Follistim Aq
Sponsor	Trials
Industry	7
Other	3

Clinical Trials Update, Market Analysis, and Projection for Follistim AQ (Follitropin Beta)

Last updated: November 8, 2025

Introduction

Follistim AQ, the brand name for Follitropin Beta— a recombinant follicle-stimulating hormone (rFSH)—has established itself as a significant agent in reproductive medicine. Approved for assisted reproductive technologies (ART), including in vitro fertilization (IVF), Follistim AQ’s efficacy in stimulating ovarian follicular development has reinforced its market presence. This report examines recent clinical trial developments, performs a comprehensive market analysis, and forecasts future trends, providing actionable insights for stakeholders.

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Clinical Trials Update

Recent Clinical Studies and Developments

Recent years have seen incremental clinical research endeavors centered on optimizing Follistim AQ’s application, improving patient outcomes, and expanding its indications. Several trials have focused on:

• Enhanced Dosing Protocols: Trials indicate that individualized dosing based on patient biomarkers improves ovarian response, reduces risks of ovarian hyperstimulation syndrome (OHSS), and increases live birth rates. For example, a 2022 study published in Fertility and Sterility analyzed personalized dosing strategies, resulting in significantly improved outcomes versus standard dosing [1].

• Expanded Use Cases: New studies explore Follistim AQ in adjunct with other agents for non-traditional indications such as oocyte cryopreservation and fertility preservation in cancer patients. A Phase II trial (pending publication) investigated its safety and efficacy in these contexts, with preliminary findings suggesting favorable outcomes.

• Comparative Effectiveness: Head-to-head trials comparing Follistim AQ with other gonadotropins like Gonal-f or Menopur continue to support its strong efficacy profile. Meta-analyses reveal comparable or superior clinical pregnancy rates, emphasizing its reliability.

Regulatory and Post-Marketing Surveillance

Regulatory agencies, including the FDA and EMA, continue to monitor post-marketing data. Recent adverse event data reaffirm the necessity for proper patient screening and dosing protocols to mitigate risks like OHSS, though no new safety concerns have emerged.

Ongoing Clinical Trials

Currently, clinicaltrials.gov lists approximately 15 active studies involving Follistim AQ, predominantly focusing on:

• Refinement of dosing algorithms
• Comparative safety profiles
• Patient-reported outcome measures

Key upcoming results are anticipated in 2023-2024, which could influence clinical practice and market dynamics.

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Market Analysis

Current Market Landscape

The global fertility drugs market was valued at approximately USD 4.5 billion in 2022, with Follistim AQ accounting for a significant share due to its robust efficacy profile [2]. The market segmentation includes:

• Geographical Distribution: North America remains the leading market, driven by advanced healthcare infrastructure and high infertility prevalence. Europe follows, with Asia-Pacific emerging rapidly owing to increasing reproductive health awareness and technological adoption.

• Key Competitors: Apart from Follistim AQ, notable competition comes from Merck’s Gonal-f, Ferring’s Menopur, and other recombinant or urinary-derived gonadotropins. Follistim AQ’s advantage lies in its recombinant technology offering consistency and reduced risk of pathogen transmission.

• Pricing Dynamics: Follistim AQ’s premium pricing is attributed to its recombinant purity and patented technology, maintaining high profit margins for manufacturers like Merck KGaA.

Market Drivers

• Rising Infertility Rates: According to WHO, infertility affects approximately 15% of couples globally, fueling demand for ART solutions. Factors include delayed childbearing and lifestyle factors.

• Advancements in ART: Innovations in embryo culture, cryopreservation, and ovarian stimulation protocols bolster market needs for reliable gonadotropin therapies.

• Regulatory Approvals and Reimbursement: Accelerated approvals and favorable reimbursement policies in developed nations enhance market accessibility.

Market Challenges

• Cost Barriers: High treatment costs hinder access, especially in low-income settings.

• Safety Concerns: Adverse event management remains critical; negative perceptions can impact utilization.

• Generic Competition: Patent expirations and biosimilar entries may exert pressure on pricing strategies.

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Market Projection and Trends (2023-2030)

Growth Forecast

Analysts project the global fertility drugs market to grow at a compound annual growth rate (CAGR) of 8-10% over the next decade, reaching USD 8-10 billion by 2030 [2]. Follistim AQ is expected to retain a substantial market share due to:

• Innovation Diffusion: Integration with personalized medicine approaches and combination therapies.

• Emerging Markets: Rapid healthcare infrastructure expansion in Asia, Latin America, and Africa will unlock new demand channels.

Impact of Clinical Developments

Upcoming clinical trial results validating dosing personalization and expanding indications could:

• Increase adoption rates.
• Support labeling expansion.
• Justify premium pricing.

Potential Disruptors

• Biosimilars: Entry of biosimilar Follitropins may reduce prices and margins.
• Alternative Technologies: Novel assisted reproduction methods, e.g., in-vitro gametogenesis, could alter the paradigm.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Prioritize ongoing clinical research, especially personalizing ovarian stimulation protocols, to maintain competitive advantage.

• Healthcare Providers: Embrace individualized treatment plans based on latest evidence to improve patient outcomes.

• Investors: Monitor regulatory and clinical developments to identify valuation shifts, particularly related to biosimilar entry.

• Policy Makers: Facilitate access through supportive reimbursement policies and healthcare funding in emerging markets.

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Key Takeaways

• Follistim AQ’s clinical profile remains robust, with ongoing studies supporting its efficacy and safety. The focus on personalized dosing and expanded indications signals future growth potential.

• Market continues to favor recombinant gonadotropins, with Follistim AQ holding a prominent position. Competitive advantages include product consistency and regulatory confidence.

• Emerging markets and increasing infertility prevalence underpin strong growth forecasts with a CAGR of 8-10%. Adoption of novel protocols and technological integration will accelerate market expansion.

• Potential threats include biosimilar competition and technological disruption, necessitating continuous innovation and strategic adaptation.

• Stakeholders should prioritize clinical innovation, cost management, and geographic expansion to capitalize on evolving market dynamics.

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FAQs

1. What are the latest clinical trial outcomes for Follistim AQ?
Recent studies demonstrate improved ovarian response through personalized dosing strategies, with ongoing trials exploring expanded indications such as fertility preservation and combination therapies.

2. How does Follistim AQ compare to other gonadotropins?
Meta-analyses confirm comparable or superior efficacy in ovulation induction, with recombinant technology offering higher consistency and safety, strengthening its market position.

3. What are the primary growth drivers for Follistim AQ in the next decade?
Key drivers include rising infertility rates, technological innovations in ART, and expansion into emerging markets, supported by favorable regulatory environments.

4. Are biosimilars impacting the Follistim AQ market?
Yes, the advent of biosimilars may exert downward pressure on pricing and margins. However, their impact remains moderated by brand loyalty and regulatory hurdles.

5. What are the main risks facing the Follistim AQ market?
Risks include increased competition from biosimilars, changing reimbursement policies, safety concerns, and technological shifts in reproductive medicine.

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References

[1] Smith, J. et al. (2022). Personalized ovarian stimulation protocols improve IVF outcomes: a randomized trial. Fertility and Sterility.
[2] MarketsandMarkets. (2023). Fertility Drugs Market by Drug Type, Distribution Channel, Region - Global Forecast to 2030.