CLINICAL TRIALS PROFILE FOR OVIDREL

All Clinical Trials for OVIDREL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00715364 ↗	REGENESIS (US): A Phase IIb Prospective, Randomized, Double-blind, Placebo Controlled Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients	Withdrawn	Stem Cell Therapeutics Corp.	Phase 2	2009-08-01	To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients. To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control.
NCT00663416 ↗	REGENESIS (CA): A Study of NTx™-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients	Terminated	Stem Cell Therapeutics Corp.	Phase 2	2008-03-01	Primary objective: To assess the neurological outcome in acute ischemic stroke patients treated with NTx™-265, when compared with patients given a placebo control. Secondary objective: To assess the safety and tolerability of NTx™-265 when given to acute ischemic stroke patients.
NCT00747617 ↗	Theca Cell Function in Women With Polycystic Ovary Syndrome (PCOS)	Completed	University of California, San Diego	Phase 3	2007-09-01	The mechanism for increased androgen production in women with polycystic ovary syndrome (PCOS) is not well understood. Excess androgen production by the ovary is stimulated by increased pituitary luteinizing hormone (LH) secretion in this disorder. The investigators hypothesize that in PCOS women ovarian theca cells, which are responsible for androgen synthesis, are more sensitive to LH stimulation compared to that of theca cells from normal women. To test this hypothesis, the investigators propose to conduct a dose-response study in which androgen responses to multiple doses of human chorionic gonadotgropin (hCG), an LH surrogate, will be assessed in PCOS and normal women.
NCT00505752 ↗	Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)	Completed	Merck KGaA	Phase 2	2007-01-01	This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
NCT00505752 ↗	Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)	Completed	Merck KGaA, Darmstadt, Germany	Phase 2	2007-01-01	This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.

Clinical Trial Conditions for OVIDREL

Condition Name

Condition Name for OVIDREL
Intervention	Trials
Infertility	12
Polycystic Ovary Syndrome	4
Stroke	3
Embryo Transfer	1

Condition MeSH

Condition MeSH for OVIDREL
Intervention	Trials
Infertility	13
Polycystic Ovary Syndrome	5
Stroke	3
Ischemic Stroke	3

Clinical Trial Locations for OVIDREL

Trials by Country

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−

Trials by Country for OVIDREL
Location	Trials
India	12
Canada	10
United States	10
Korea, Republic of	3
China	3

Trials by US State

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−

Trials by US State for OVIDREL
Location	Trials
California	5
Virginia	2
Utah	1
Ohio	1
Massachusetts	1

Clinical Trial Progress for OVIDREL

Clinical Trial Phase

Clinical Trial Phase for OVIDREL
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for OVIDREL
Clinical Trial Phase	Trials
Completed	13
Unknown status	8
Recruiting	3

Clinical Trial Sponsors for OVIDREL

Sponsor Name

Sponsor Name for OVIDREL
Sponsor	Trials
Merck KGaA	3
Merck KGaA, Darmstadt, Germany	3
Stem Cell Therapeutics Corp.	3

Sponsor Type

Sponsor Type for OVIDREL
Sponsor	Trials
Industry	19
Other	18

OVIDREL: Clinical Trials, Market Analysis, and Projections

Introduction

OVIDREL, also known as choriogonadotropin alfa, is a recombinant human chorionic gonadotropin (hCG) used in assisted reproductive technology (ART) and ovulation induction (OI). Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Comparative Studies with Urinary hCG

Several clinical trials have compared the efficacy and safety of OVIDREL with traditional urinary-derived hCG. A key study involved 297 ovulatory infertile women undergoing ART, who were randomized to receive either 250 μg or 500 μg of recombinant hCG or 10,000 U of urinary hCG. The results showed that the mean numbers of oocytes retrieved per patient were equivalent across the groups, indicating that 250 μg of recombinant hCG is clinically and statistically equivalent to 10,000 U of urinary hCG[1][3][5].

Ovulation Induction

In another double-blind, randomized, multicenter study (Study 8209), OVIDREL 250 μg was compared to 5,000 IU of urinary-derived hCG in anovulatory infertile women. The study found that OVIDREL 250 μg had a similar ovulation rate and clinical pregnancy rate to the urinary-derived hCG, with an ovulation rate of 91.9% and a clinical pregnancy rate of 22%[3][5].

Pharmacokinetics and Pharmacodynamics

Pharmacokinetic studies have shown that OVIDREL has a median elimination half-life of approximately 29 hours and a total body clearance of about 0.51 L/hr. The pharmacodynamic effects of OVIDREL are complex and not always proportional to the dose, with significant effects often observed at the 250 μg dose[3].

Safety and Tolerability

The clinical trials have also assessed the safety and tolerability of OVIDREL. While the drug is generally well-tolerated, higher doses (500 μg) have been associated with a slightly higher incidence of adverse events compared to the lower dose (250 μg)[1][3].

Market Analysis

Global Infertility Drugs Market

The global infertility drugs market, which includes OVIDREL, was valued at USD 3,480.14 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 6.1% from 2023 to 2030, reaching USD 5.6 billion by 2030. The gonadotropin segment, which includes recombinant hCG products like OVIDREL, accounted for 39.96% of the market share in 2022 due to their high efficacy and immediate results[2].

Market Segments

The market is segmented by drug class, end-user, distribution channel, and region. The gonadotropin segment is expected to continue its dominance due to the high prescription and usage rates. The market is also driven by advancements in fertility technologies and the introduction of novel medicines, such as OXO-001, which aims to enhance embryo implantation[2].

Regional Outlook

The global infertility drugs market is diverse, with significant contributions from regions such as North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are among the leading regions due to advanced healthcare infrastructure and higher awareness of fertility treatments. The Asia Pacific region is also expected to grow significantly due to increasing demand and improving healthcare facilities[2].

Future Projections

Market Growth

The increasing prevalence of infertility, advancements in fertility treatments, and the introduction of new products are expected to drive the market growth. The development of first-in-class products like OXO-001, which enhances embryo implantation, addresses a significant medical need and is likely to contribute to the market expansion[2].

Technological Advancements

The integration of advanced fertility technologies, such as those offered by EMD Serono's Fertility Technologies unit, is expected to improve treatment outcomes. These technologies, including improved injection devices and disease monitoring software, will enhance patient care and treatment efficacy[4].

Key Takeaways

• Efficacy and Safety: OVIDREL is clinically and statistically equivalent to urinary-derived hCG in inducing final follicular maturation and ovulation.
• Market Growth: The global infertility drugs market is expected to grow at a CAGR of 6.1% from 2023 to 2030.
• Segment Dominance: The gonadotropin segment, including OVIDREL, dominates the market due to its high efficacy.
• Regional Expansion: North America, Europe, and the Asia Pacific are key regions driving market growth.
• Technological Advancements: Integration of advanced fertility technologies is expected to improve treatment outcomes.

FAQs

What is OVIDREL used for?

OVIDREL is used for the induction of final follicular maturation and early luteinization in infertile women undergoing assisted reproductive technology (ART) and for ovulation induction (OI)[3][5].

How does OVIDREL compare to urinary-derived hCG?

Clinical trials have shown that OVIDREL 250 μg is clinically and statistically equivalent to 10,000 U of urinary-derived hCG in terms of efficacy and safety[1][3][5].

What is the expected market growth for infertility drugs?

The global infertility drugs market is expected to grow at a CAGR of 6.1% from 2023 to 2030, reaching USD 5.6 billion by 2030[2].

Which segment dominates the infertility drugs market?

The gonadotropin segment, which includes recombinant hCG products like OVIDREL, dominates the market due to its high efficacy and immediate results[2].

What are the key regions driving the market growth?

North America, Europe, and the Asia Pacific are the key regions driving the growth of the infertility drugs market[2].

How do technological advancements impact the market?

Technological advancements, such as improved injection devices and disease monitoring software, are expected to enhance patient care and treatment outcomes, contributing to market growth[4].

Sources

1. Clinical Trial: "Recombinant human chorionic gonadotropin (rhCG) versus urinary hCG for final oocyte maturation in IVF: results of a randomized clinical trial."
2. Market Report: "Infertility Drugs Market Size, Share & Growth Report, 2030" - Grand View Research.
3. Product Information: "Ovidrel® PreFilled Syringe" - EMD Serono.
4. Company Overview: "Healthcare" - EMD Group.
5. DailyMed: "OVIDREL- choriogonadotropin alfa injection, solution" - DailyMed.