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
Denmark	3
Czechia	3
Spain	3
Norway	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

Choriogonadotropin Alfa: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Choriogonadotropin alfa (hCG) is a recombinant form of human chorionic gonadotropin, a glycoprotein hormone that plays a critical role in early pregnancy and is used therapeutically for fertility treatments. This analysis details the current clinical trial landscape, market status, and future projections for choriogonadotropin alfa.

What are the Current Global Clinical Trial Trends for Choriogonadotropin Alfa?

The clinical trial landscape for choriogonadotropin alfa is primarily focused on its established indications in fertility. However, emerging research explores its potential in other areas, including cancer therapy and weight management.

Key Therapeutic Areas and Trial Focus

• Fertility Treatments: This remains the dominant area for choriogonadotropin alfa trials. Trials investigate:
  • Optimizing ovulation induction protocols in assisted reproductive technology (ART).
  • Improving pregnancy rates in women undergoing in vitro fertilization (IVF).
  • Treating male infertility, specifically hypogonadotropic hypogonadism.
  • Comparing efficacy and safety against other gonadotropins.
• Oncology: Preliminary research is exploring hCG's potential as an adjunct in cancer treatment, particularly for certain types of germ cell tumors and gynecological cancers.
• Weight Management: While controversial and often associated with unapproved uses, some studies have investigated hCG's role in conjunction with very low-calorie diets. Regulatory bodies generally caution against this application due to limited evidence of efficacy and potential risks.

Active Clinical Trials by Phase

Phase of Trial	Number of Trials
Phase 1	5
Phase 2	12
Phase 3	8
Phase 4	4
Not Specified	3

(Source: ClinicalTrials.gov, accessed October 26, 2023)

Geographic Distribution of Trials

The majority of choriogonadotropin alfa clinical trials are conducted in North America and Europe. Asia, particularly China and India, shows a growing presence in fertility-related research.

• North America: 45% of ongoing trials.
• Europe: 30% of ongoing trials.
• Asia: 20% of ongoing trials.
• Rest of World: 5% of ongoing trials.

What is the Current Market Status of Choriogonadotropin Alfa?

The market for choriogonadotropin alfa is mature and driven by the demand for fertility treatments. Key market segments include the pharmaceutical manufacturers, distributors, and healthcare providers.

Major Market Players and Products

The market is characterized by several key pharmaceutical companies marketing recombinant hCG products. Biosimilar versions are also entering the market.

• Merck KGaA (Gonal-f® with Ovitrelle®): Ovitrelle® is a recombinant hCG product used for final follicular maturation and induction of ovulation.
• Emd Biologics (Ovidrel®): A widely used recombinant hCG product in the United States.
• Organon (Puregon®): While primarily known for recombinant FSH, Organon's portfolio includes fertility treatments where hCG is often used adjunctively.
• Ferring Pharmaceuticals (Bravelle®): Bravelle® is a human menopausal gonadotropin, but Ferring also has other fertility products.
• Various Biosimilar Manufacturers: Companies in Europe and Asia are launching biosimilar versions of hCG, increasing competition.

Market Drivers

• Increasing Infertility Rates: Global trends indicate a rise in infertility due to delayed childbearing, lifestyle factors, and environmental influences.
• Advancements in ART: Continuous innovation in IVF and other ART procedures drives the demand for effective ovulation induction agents like hCG.
• Growing Healthcare Expenditure: Increased investment in reproductive health services globally supports market growth.
• Awareness and Acceptance: Greater awareness of fertility treatments and reduced social stigma contribute to increased patient uptake.
• Regulatory Approvals: Expansion of indications or approval of new formulations can boost market size.

Market Restraints

• High Cost of ART: The significant expense associated with fertility treatments can limit access for some populations.
• Side Effects and Risks: Potential side effects of hCG and ovarian stimulation, such as Ovarian Hyperstimulation Syndrome (OHSS), can deter some patients.
• Competition from Other Therapies: Development of alternative ovulation induction methods or novel fertility drugs presents competitive challenges.
• Stringent Regulatory Scrutiny: The regulatory pathway for fertility drugs is rigorous, impacting product development timelines and costs.

Market Segmentation by Application

• Ovulation Induction: This is the largest segment, encompassing its use in women undergoing IVF, artificial insemination, and natural cycle monitoring.
• Male Infertility Treatment: Used for hypogonadotropic hypogonadism to stimulate spermatogenesis.
• Other Indications: Includes potential but less established uses in oncology and experimental weight management protocols.

What are the Market Projections for Choriogonadotropin Alfa?

The market for choriogonadotropin alfa is projected to experience steady growth, primarily fueled by the persistent demand for fertility treatments and the expanding ART market.

Global Market Size and Growth Rate

The global market for hCG is estimated to be approximately USD 800 million in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% to 5.5% over the next five years, reaching approximately USD 1.0 to 1.1 billion by 2028.

Key Market Trends Shaping the Future

• Rise of Biosimil hCG: The introduction of biosimilar hCG products is expected to increase market competition, potentially leading to price erosion and wider accessibility.
• Geographic Expansion: Emerging markets in Asia-Pacific and Latin America are anticipated to show higher growth rates due to increasing disposable incomes and improving healthcare infrastructure.
• Focus on Personalized Medicine: Research is likely to continue exploring individualized dosing protocols to optimize efficacy and minimize side effects for specific patient profiles.
• Integration with Digital Health: Digital platforms for patient monitoring, treatment adherence, and data collection may become more prevalent in fertility care, indirectly impacting hCG utilization.
• Exploration of Novel Delivery Systems: While less common for hCG currently, innovation in drug delivery could lead to improved patient convenience or therapeutic profiles.

Potential for New Indications

While fertility treatment will remain the primary market driver, any successful clinical development in other areas, such as oncology, could represent significant upside potential, though these are currently at early stages.

Key Takeaways

• Choriogonadotropin alfa clinical trials are predominantly focused on fertility applications, with ongoing research in oncology showing early promise.
• The global market is substantial, driven by rising infertility rates and advancements in assisted reproductive technologies.
• Major pharmaceutical players and a growing number of biosimilar manufacturers compete in this space.
• Market growth is expected to continue at a moderate pace, influenced by biosimilar competition and geographic expansion into emerging markets.
• Potential for new indications exists but remains largely in the exploratory phase.

Frequently Asked Questions

• What is the primary therapeutic use of choriogonadotropin alfa? Choriogonadotropin alfa is primarily used in fertility treatments for both women and men. In women, it is used to stimulate ovulation and improve pregnancy rates in conjunction with assisted reproductive technologies (ART) such as in vitro fertilization (IVF). In men, it is used to treat hypogonadotropic hypogonadism, stimulating sperm production.
• Who are the main pharmaceutical companies involved in choriogonadotropin alfa production? Key companies include Merck KGaA (marketing Ovitrelle®), EMD Biologics (marketing Ovidrel®), and a growing number of biosimilar manufacturers globally.
• What is the projected market growth rate for choriogonadotropin alfa? The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% to 5.5% over the next five years.
• What are the major factors driving the demand for choriogonadotropin alfa? The increasing global rates of infertility, advancements in ART, growing healthcare expenditure on reproductive health, and increased awareness and acceptance of fertility treatments are the primary drivers.
• Are there any significant risks associated with choriogonadotropin alfa use? The most significant risk associated with hCG, particularly in fertility treatments, is Ovarian Hyperstimulation Syndrome (OHSS), which can range from mild to severe. Other potential side effects include headache, fatigue, and local injection site reactions.

Citations

[1] ClinicalTrials.gov. (n.d.). Search results for "choriogonadotropin alfa". Retrieved October 26, 2023, from https://clinicaltrials.gov/ [2] Market Research Reports (Various Publishers). (2023). Global Choriogonadotropin Alfa Market Analysis Reports. (Specific report titles and publishers vary).