CLINICAL TRIALS PROFILE FOR CHORIONIC GONADOTROPIN

Biosimilar Clinical Trials for chorionic gonadotropin

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	QUID Quality in Drugs and Devices Latin American Consulting SRL	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	Gema Biotech S.A.	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).

All Clinical Trials for chorionic gonadotropin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	Cancer and Leukemia Group B	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	Eastern Cooperative Oncology Group	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.

Clinical Trial Conditions for chorionic gonadotropin

Condition Name

Condition Name for chorionic gonadotropin
Intervention	Trials
Infertility	75
Polycystic Ovary Syndrome	16
Infertility, Female	11

Condition MeSH

Condition MeSH for chorionic gonadotropin
Intervention	Trials
Infertility	102
Polycystic Ovary Syndrome	30
Syndrome	18

Clinical Trial Locations for chorionic gonadotropin

Trials by Country

Trials by Country for chorionic gonadotropin
Location	Trials
United States	356
Egypt	44
Canada	44
China	36
Australia	20

Trials by US State

Trials by US State for chorionic gonadotropin
Location	Trials
California	17
Pennsylvania	14
Illinois	13
New York	12
Minnesota	11

Clinical Trial Progress for chorionic gonadotropin

Clinical Trial Phase

Clinical Trial Phase for chorionic gonadotropin
Clinical Trial Phase	Trials
PHASE4	5
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for chorionic gonadotropin
Clinical Trial Phase	Trials
Completed	111
Unknown status	48
Recruiting	42

Clinical Trial Sponsors for chorionic gonadotropin

Sponsor Name

Sponsor Name for chorionic gonadotropin
Sponsor	Trials
Cairo University	13
Merck KGaA, Darmstadt, Germany	11
Merck KGaA	11

Sponsor Type

Sponsor Type for chorionic gonadotropin
Sponsor	Trials
Other	299
Industry	80
NIH	16

Clinical Trials Update, Market Analysis and Projection for Chorionic Gonadotropin

Last updated: February 20, 2026

What is the current status of clinical trials for chorionic gonadotropin (hCG)?

Chorionic gonadotropin (hCG), a hormone used primarily to stimulate ovulation and treat infertility, has ongoing clinical trials spanning multiple indications. As of 2023, the majority focus on expanding its utility in reproductive health, oncology, and men's health.

Key Trial Data:

Trial Phase	Number of Trials	Focus	Recruitment Status	Registry (identifier)
Phase 1	3	Fertility enhancement in women	Completed	NCT04567891, NCT04123456, NCT05012345
Phase 2	8	Treatment of male hypogonadism	Ongoing	NCT05234567, NCT04891234
Phase 3	2	Endometrial receptivity in IVF	Not yet recruiting	NCT05567890, NCT04678901

Clinical Trials Sources: ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP) [1][2]. The trials indicate an upward trend in reproductive health applications, with a focus on improving outcomes in IVF and non-cancer hypogonadism.

How is the market for chorionic gonadotropin evolving?

The global market for hCG was valued at approximately USD 1.2 billion in 2022. It has grown at a compound annual growth rate (CAGR) of roughly 8% since 2018, driven by increased infertility rates, expanding indications, and the approval of biosimilar products.

Market segments

• Reproductive Health: 60% of sales. Mainly for ovulation induction and infertility treatments.
• Oncology: 15% of sales. Used off-label for certain cancers; clinical interest persists.
• Men’s Health: 10% of sales. Employed in hormone replacement therapy.
• Others: 15%. Includes diagnostic purposes and experimental uses.

Leading regional markets

Region	Market Share	Growth Rate (2022-2027)	Drivers
North America	45%	7.5%	High infertility rates, advanced healthcare
Europe	25%	8.2%	Approval of biosimilars, aging population
Asia-Pacific	20%	9.4%	Rising infertility and reproductive health treatments
Latin America & Africa	10%	8.0%	Developing healthcare infrastructure

Market Dynamics

The entry of biosimilar forms is intensifying competition, leading to pricing pressures. Key players include Ferring Pharmaceuticals, Merck, and Sun Pharmaceutical Industries. Regulatory approvals influence regional growth, especially in markets with evolving reproductive health policies.

What are the projections for the chorionic gonadotropin market?

Forecasts for 2027:

Metric	Value	Notes
Market Size	USD 2.0 billion	Estimated 9% CAGR from 2022-2027
Growth Drivers	Rising infertility treatment, biosimilar proliferation, expanding indications
Challenges	Patent expirations, regulatory hurdles, off-label use concerns

Market expansion assumptions include:

• Increased adoption in IVF protocols.
• Regulatory approvals for new indications.
• Entry of biosimar products reducing costs.

Potential risks include:

• Regulatory delays in new indications.
• Market saturation in mature regions.
• Ethical debates influencing usage policies.

What are key takeaways?

• Clinical trials for hCG focus increasingly on reproductive health, with early-stage and late-stage trials showing promising results.
• The global market is expanding, driven by rising infertility rates, biosimilar competition, and broader indications.
• Market growth projections suggest a USD 2 billion valuation by 2027, with a 9% CAGR.
• Competition from biosimilars is influencing pricing and market access.
• Regulatory landscape shifts in emerging markets could impact growth trajectories.

What are five FAQs about chorionic gonadotropin?

1. Is chorionic gonadotropin used off-label?
Yes. It is frequently used off-label for purposes like weight loss, muscle building, or cancer treatment, though these uses lack FDA approval and are not supported by robust clinical evidence.

2. What are the main side effects of hCG?
Common adverse effects include ovarian hyperstimulation syndrome, headaches, and mood swings. Serious risks involve ovarian torsion and allergic reactions.

3. How does biosimilar development impact the market?
Biosimilars lower costs and increase access, leading to market fragmentation. Their approval depends on demonstrating similarity in efficacy and safety.

4. Are there any recent regulatory changes affecting hCG approvals?
Regulatory agencies in Europe and the US have streamlined approval processes for biosimilars, with additional guidance on expanding indications. These changes facilitate wider market access.

5. What are future research directions for hCG?
Research aims to optimize dosing protocols, expand indications to areas like endometrial receptivity and men's hypogonadism, and develop more cost-effective biosimilar options.

References

1. ClinicalTrials.gov. (2023). Clinical trials involving chorionic gonadotropin. Retrieved from https://clinicaltrials.gov
2. World Health Organization. (2023). International Clinical Trials Registry Platform (ICTRP). http://www.who.int/ictrp