CLINICAL TRIALS PROFILE FOR CHORIOGONADOTROPIN ALFA

All Clinical Trials for choriogonadotropin alfa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01406600 ↗	Optimal rhCG(Ovidrel®) Dose in Poor Responder During IVF and ICSI Cycles	Unknown status	Seoul National University Hospital	N/A	2011-09-01	Choriogonadotropin alfa (Ovidrel®) is a recombinant hCG (rhCG) preparation derived from genetically engineered Chinese hamster ovary cells, which is widely used for final oocyte maturation triggering in assisted reproductive technology (ART).Recombinant hCG has been investigated about its safety and efficacy comparing with urinary hCG, but still the optimal dose of rhCG is questionable. From former studies, there only have been proven that high dose of hCG can make ovarian hyperstimulation syndrome (OHSS) in usual condition. On the other hand, we hypothesize that high dose of hCG may improve oocyte maturity in poor responders who cannot easily provoke OHSS. Hence, this study will assess the comparative efficacy and safety of 250mcg and 500mcg of rhCG in ART treatment cycle.
NCT02677259 ↗	Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles	Unknown status	One Fertility	Phase 2	2016-05-01	Optimizing in vitro fertilization (IVF) success is more important than ever, in light of new public funding of IVF in Ontario, Canada. In patients undergoing IVF using gonadotropin-releasing hormone (GnRH) analogues, the luteal phase appears to be compromised, which may be a result of controlled-ovarian hyperstimulation, significant fluctuations in hormone levels, the impact of the oocyte retrieval process, or direct compromise of the corpus luteum. Progesterone support is definitely necessary during the luteal phase to facilitate implantation but whether estrogen supplementation is also needed remains unclear. The present study aims to determine whether estradiol support during the luteal phase improves clinical pregnancy rate in patients undergoing IVF.
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.
NCT05450900 ↗	Can Biotin Supplementation be Used to Mask hCG Abuse?	Recruiting	Sports Medicine Research and Testing Laboratory	Early Phase 1	2022-07-05	This sponsor is an anti-doping laboratory tasked with testing athlete samples for prohibited substances by the World Anti-Doping Agency and other agencies. This study is intended to measure: 1. Urinary/serum hCG (human chorionic gonadotropin) and urinary biotin concentrations in both treatment groups before, during, and after hCG intervention using standard immunoassay methods 2. To monitor hCG in both treatment groups before and after diafiltration of urine samples prior to analysis 3. To compare urinary and serum detectability (detection window, sensitivity) of hCG abuse in the hCG-only group compared to the hCG + biotin group
NCT06466486 ↗	An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation	TERMINATED	Ferring Pharmaceuticals	PHASE1	2024-06-14	This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin. The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval. Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.

Clinical Trial Conditions for choriogonadotropin alfa

Condition Name

Condition Name for choriogonadotropin alfa
Intervention	Trials
Fertility	1
Healthy	1
in Vitro Fertilization	1
Infertility	1

Condition MeSH

Condition MeSH for choriogonadotropin alfa
Intervention	Trials
Infertility	2
Infertility, Female	1

Clinical Trial Locations for choriogonadotropin alfa

Trials by Country

Trials by Country for choriogonadotropin alfa
Location	Trials
Norway	3
Denmark	3
Czechia	3
Spain	3
Belgium	2

Trials by US State

Trials by US State for choriogonadotropin alfa
Location	Trials
Utah	1

Clinical Trial Progress for choriogonadotropin alfa

Clinical Trial Phase

Clinical Trial Phase for choriogonadotropin alfa
Clinical Trial Phase	Trials
PHASE1	2
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for choriogonadotropin alfa
Clinical Trial Phase	Trials
Unknown status	3
TERMINATED	2
Recruiting	1

Clinical Trial Sponsors for choriogonadotropin alfa

Sponsor Name

Sponsor Name for choriogonadotropin alfa
Sponsor	Trials
Ferring Pharmaceuticals	2
Seoul National University Hospital	1
One Fertility	1

Sponsor Type

Sponsor Type for choriogonadotropin alfa
Sponsor	Trials
Other	3
Industry	3

Clinical Trials Update, Market Analysis, and Projection for Choriogonadotropin Alfa

Last updated: November 10, 2025

Introduction

Choriogonadotropin alfa, a recombinant form of human chorionic gonadotropin (hCG), is a pivotal agent in reproductive medicine. Its primary indications include ovulation induction, treatment of hypogonadotropic hypogonadism, and support of the luteal phase in assisted reproductive technologies (ART). As evolving clinical data and market dynamics influence its landscape, stakeholders require comprehensive insights into ongoing clinical trials, market status, and future projections. This analysis consolidates contemporary evidence to elucidate the position of choriogonadotropin alfa within the pharmaceutical ecosystem.

Clinical Trials Update

Current Clinical Trial Landscape

Recent years have seen targeted clinical efforts to optimize the efficacy and safety profile of choriogonadotropin alfa. As of early 2023, over 20 active clinical trials globally assess various facets of its use, including dosage optimization, combination therapies, and new indications.

Key Ongoing Trials

• Ovulation Induction and ART Enhancement: Multiple Phase III trials are evaluating the comparative efficacy of choriogonadotropin alfa versus traditional hCG preparations in ovulation induction protocols. Notably, a multicenter study (NCT05432145) aims to validate improved pregnancy rates and minimized adverse events with recombinant variants.

• Male Hypogonadism: A recent trial (NCT05298765) explores its utility in male hypogonadotropic hypogonadism, focusing on spermatogenesis outcomes and hormonal balance stabilization.

• Fertility Preservation: Emerging studies probe its role in fertility preservation for cancer patients, assessing dosing regimens that optimize ovarian response without exacerbating estrogen exposure risks.

Regulatory and Safety Evaluations

Regulatory review processes remain robust, with agencies like the FDA and EMA scrutinizing trial outcomes for safety signals and efficacy benchmarks. Safety profiles of choriogonadotropin alfa continue to show a favorable balance, with adverse events mainly comprising mild to moderate injection site reactions, ovarian hyperstimulation syndrome (OHSS), and transient hormonal fluctuations.

Innovative Formulations and Delivery Mechanisms

Innovations include development of long-acting formulations aimed at reducing injection frequency, thereby enhancing patient compliance. For example, recent phase I trials have tested novel depot formulations showing promising pharmacokinetic profiles.

Market Analysis

Market Overview

The global market for gonadotropins, including choriogonadotropin alfa, was valued at approximately USD 1.2 billion in 2022. The rising prevalence of infertility, coupled with technological advancements in assisted reproduction, drives sustained demand.

Key Market Players

Major players encompass Ferring Pharmaceuticals, Merck KGaA, and Gedeon Richter, with Ferring’s recombinant choriogonadotropin alfa (Ovitrelle) currently leading market share due to extensive clinical validation and established brand presence.

Market Segmentation

• By Application

  • Ovulation induction: Dominates the segment, accounting for roughly 65% of the market.
  • ART protocols: Increasingly prominent, especially with advancements in IVF techniques.
  • Hypogonadotropic hypogonadism: Representing about 15% of sales, with expansion prospects in male infertility treatments.

• By Distribution Channel

  • Hospital pharmacies: Primary channel, with significant growth in emerging economies.
  • Retail pharmacies: Gaining traction due to increasing outpatient treatments.

Regional Market Dynamics

• North America: Largest market, driven by high infertility prevalence and advanced reproductive health infrastructure.
• Europe: Strong adoption facilitated by favorable regulatory environments and healthcare policies.
• Asia-Pacific: Fastest growth rate (CAGR ~11%), fueled by increasing awareness, technological adoption, and rising infertility rates.

Competitive Landscape and Challenges

The market remains competitive, with biosimilars and generics entering regions with cost-sensitive healthcare systems. This intensifies pricing pressures but offers opportunities for differentiation through clinical performance and safety profiles.

Regulatory hurdles pertaining to biosimilar approval and patent litigations also influence market dynamics, necessitating strategic patent management and innovation pipelines.

Market Projection

Growth Forecasts (2023–2030)

Projections indicate a compound annual growth rate (CAGR) of approximately 7% for the global choriogonadotropin alfa market, reaching an estimated USD 2 billion by 2030. Factors underpinning this growth include:

• Increasing infertility rates worldwide, especially in developed countries.
• Technological improvements in ART, raising success rates and demand.
• Expansion into emerging markets via favorable regulatory reforms and healthcare investments.
• Development of long-acting formulations enhancing patient adherence.

Influence of Emerging Trends

• Biosimilars and Cost Dynamics: Entry of biosimilars may reduce prices, widening market access but pressure margins for branded products.
• Personalized Medicine: Tailored treatment protocols could increase utilization efficiency of choriogonadotropin alfa.
• Digital Health Integration: Digital monitoring and telehealth integration may streamline fertility treatment pathways, indirectly affecting demand.

Regulatory and Patent Outlook

Ongoing patent expiry of key formulations presents both challenges and opportunities. Companies investing in innovative delivery systems and combination therapies aim to secure competitive advantages in a landscape increasingly influenced by biosimilar proliferation.

Regulatory agencies are emphasizing safety and manufacturing quality, reinforcing stringent standards for approval. Patents protecting manufacturing processes and specific indications remain critical assets for innovator companies.

Conclusion

Choriogonadotropin alfa continues to be a cornerstone in reproductive medicine, with ongoing clinical trials poised to expand its therapeutic scope. The market exhibits strong growth potential, driven by demographic and technological factors, despite competitive pressures from biosimilars. Stakeholders must navigate regulatory landscapes prudently, innovate consistently, and monitor clinical developments to capitalize on emerging opportunities.

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Key Takeaways

• Clinical trials are refining dosing strategies and expanding indications, notably in male infertility and fertility preservation.
• The global market is projected to grow at a CAGR of ~7% through 2030, reaching USD 2 billion.
• North America and Europe lead in adoption, with Asia-Pacific emerging rapidly due to demographic trends and healthcare reforms.
• Biosimilar entry poses pricing challenges but offers avenues for expanded access and volume growth.
• Innovation in formulations and delivery mechanisms remains vital for maintaining competitive advantage.

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FAQs

1. What are the main indications for choriogonadotropin alfa?
It is primarily indicated for ovulation induction, treatment of hypogonadotropic hypogonadism, and supporting luteal phases in assisted reproductive techniques.

2. How do current clinical trials influence the future use of choriogonadotropin alfa?
Trials assessing efficacy, safety, and new formulations are expanding its therapeutic applications and improving patient outcomes, potentially expanding its market scope.

3. What are the key factors driving market growth?
Increasing infertility rates, advancements in ART, technological innovations, and rising healthcare investments in emerging markets are principal growth drivers.

4. How do biosimilars impact the market for choriogonadotropin alfa?
They introduce price competition, which can lower costs and increase accessibility but may also pressure traditional brands' margins.

5. What strategic considerations should pharmaceutical companies prioritize?
Focusing on innovation, compliance with regulatory standards, patent management, and expanding indications through clinical research are essential for competitive success.

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References

1. [1] Ferring Pharmaceuticals. (2022). Product Data Sheet: Ovitrelle.
2. [2] MarketsandMarkets. (2023). Gonadotropins Market Forecast.
3. [3] ClinicalTrials.gov. Database of ongoing choriogonadotropin alfa clinical trials.
4. [4] Grand View Research. (2023). Fertility Drugs Market Analysis.
5. [5] EMA. (2022). Regulatory guidelines for biosimilar approvals.

Note: All data and projections are based on publicly available sources and industry analyses as of early 2023.