CLINICAL TRIALS PROFILE FOR CETROTIDE

All Clinical Trials for CETROTIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00298025 ↗	A Study to Compare the Safety and Efficacy of Cetrotide® 3 Milligram (mg) Versus Antagon™ in Women Undergoing Ovarian Stimulation	Completed	EMD Serono	Phase 4	2003-09-01	To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.
NCT00439829 ↗	Synchronization of Follicle Wave Emergence and Ovarian Stimulation	Completed	Royal University Hospital Foundation	Phase 4	2007-02-01	The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00439829 ↗	Synchronization of Follicle Wave Emergence and Ovarian Stimulation	Completed	University of Saskatchewan	Phase 4	2007-02-01	The objective of the study is to elucidate the effect of synchronizing initiation of ovarian stimulation treatment with follicular wave emergence in poor responder patients undergoing IVF/ICSI and ET. We hypothesize that initiating treatment on day 1 versus day 4 of the cycle will increase the number of follicles recruited and oocytes retrieved.
NCT00460642 ↗	GnRH Antagonist to Prepare Recipients for Embryo Transfer	Completed	Institute for Human Reproduction (IHR)	N/A	2007-01-01	26% of all ART cycles performed in the USA in 2003 (CDC data) are frozen embryo transfers (FET) and transfer of embryos resulting from egg donation (ED) to recipients. The typical protocol used to prepare a recipient for ET involves GnRH agonist (Lupron, Tap Pharmaceuticals) to down regulate the patient. A GnRH antagonist, such as Cetrotide (EMD Serono), is comparable to GnRH agonist and FDA approved to prevent spontaneous ovulation with ART treatment, and its usage decreases significantly the number of injections that the patient receives with treatment. The working hypothesis for this study is that the GnRH antagonist (Cetrotide) can be used instead of an agonist to achieve effective down regulation in FET and ED cycles. Presumably, patients will prefer Cetrotide over Lupron because of the markedly fewer injections required.
NCT00507780 ↗	Effect of Cetrorelex Acetate on Ovarian Function in Women Undergoing Chemotherapy	Withdrawn	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 4	2007-07-18	This study will examine whether the drug cetrorelex acetate (Cetrotide[Registed Trademark]) can protect ovarian function in women undergoing chemotherapy. Some cancer treatments are known to cause a change in women's periods or to cause menstruation to stop completely, so that they cannot become pregnant. Cetrorelex acetate has been used for many years to lower hormone levels and stop periods in patients undergoing in vitro fertilization treatments. This study will see if making the ovaries inactive may protect them from being affected by certain cancer drugs, and thus preserve fertility. Women up to age 21who have begun menstruating, who have their uterus and at least one functioning ovary, and who are undergoing chemotherapy with cyclophosphamide, busulfan, nitrogen mustard or L-phenalanin mustard may be eligible for this study. Participants undergo the following procedures during this 24-month study: Baseline evaluation - Medical history, physical examination and blood and urine tests - Questionnaire about quality of life, menstrual periods, vaginal bleeding and desire for future fertility - 3D ultrasound of abdomen - DEXA scan to evaluate bone density Assignment to treatment with: - Lo ovral (contraceptive pill to prevent pregnancy and control menstrual periods) alone, or - Lo ovral and the study drug cetrorelex acetate, given as an injection under the skin once a day for six menstrual cycles Evaluations - Transvaginal 3D ultrasound to monitor changes in the ovary - after 6 months of cetrorelex acetate injections - DEXA scan - after 6 months of cetrorelex acetate injections - Blood tests for safety monitoring, pregnancy testing, endocrine tests and research uses - every 3 months during first year, every 6 months during second year - Questionnaire to monitor changes and quality of life - every 3 months during first year, every 6 months during second year.
NCT00633347 ↗	Use of Antagonist Versus Agonist GnRH in Oocyte Recipient Endometrium Preparation	Completed	Instituto Valenciano de Infertilidad, IVI VALENCIA	Phase 4	2007-01-01	Oocyte donation is a well established procedure in assisted reproduction treatments (ART). It is demonstrated that the use of hormonal substitution therapy, for the synchronization of the cycles between the recipients and the donors, provides good results, similar to the ones obtained with the natural cycle. In the patients - recipients with preserved ovarian function, the recipient's natural cycle is annulled, thus preventing the spontaneous Luteinizing Hormone surge. Simultaneously and while waiting for the suitable donor, her endometrium is prepared. When the donation occurs and fertilization with the husband sperm takes place, her cycle is stimulated again in order to synchronize her window of implantation with the donor's ovulation. Two different medications are commonly used to inhibit spontaneous ovulation: either GnRHa agonist or GnRH antagonists. The present study consists of the comparison between the single dose GnRH agonist (Decapeptyl 3,75 IM) and the 7 day dosage of GnRH antagonist (Cetrotide 0,25 mg). The administration of GnRHa is used fundamentally as a long liberation formulation, administered in a single intramuscular injection (IM), which is more practical in terms of use. Nevertheless, the unnecessary persistence and the potentially unfavorable action of GnRHa during the luteal phase and early gestation have questioned its use. The recovery of the Hypophysarian function begins only 8 weeks after the single injection of long liberation of triptorelina 3.75 mg. The GnRH antagonist (Cetrotide 0,25 mg) makes the hypofisary inhibition shorter than with the analogues and can prepare similar endometrium characteristics as a natural cycle. The recipients will be assigned randomly to a group of treatment or another.

Clinical Trial Conditions for CETROTIDE

Condition Name

Condition Name for CETROTIDE
Intervention	Trials
Infertility	20
Subfertility	5
Infertility, Female	4
Invitro Fertilization	3

Condition MeSH

Condition MeSH for CETROTIDE
Intervention	Trials
Infertility	33
Infertility, Female	5
Syndrome	4
Ovarian Hyperstimulation Syndrome	4

Clinical Trial Locations for CETROTIDE

Trials by Country

Trials by Country for CETROTIDE
Location	Trials
Egypt	19
United States	6
India	3
Canada	3
Spain	2

Trials by US State

Trials by US State for CETROTIDE
Location	Trials
Colorado	2
Texas	1
Virginia	1
Maryland	1
Illinois	1

Clinical Trial Progress for CETROTIDE

Clinical Trial Phase

Clinical Trial Phase for CETROTIDE
Clinical Trial Phase	Trials
PHASE3	2
Phase 4	16
Phase 3	10

Clinical Trial Status

Clinical Trial Status for CETROTIDE
Clinical Trial Phase	Trials
Completed	29
Unknown status	10
Recruiting	8

Clinical Trial Sponsors for CETROTIDE

Sponsor Name

Sponsor Name for CETROTIDE
Sponsor	Trials
Cairo University	11
University of Colorado, Denver	3
Merck KGaA	3

Sponsor Type

Sponsor Type for CETROTIDE
Sponsor	Trials
Other	62
Industry	11
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Cetrotide

Last updated: October 30, 2025

Introduction

Cetrotide (fremareline acetate) is an injectable gonadotropin-releasing hormone (GnRH) antagonist primarily used in assisted reproductive technology (ART) procedures, including in vitro fertilization (IVF), to prevent premature luteinizing hormone (LH) surges. The drug's mechanism effectively suppresses premature ovulation, optimizing the timing for embryo transfer and improving pregnancy outcomes. As a staple in fertility treatments, Cetrotide's market dynamics are subject to ongoing clinical developments, evolving regulatory landscapes, and the shifting scope of reproductive health demands worldwide.

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Clinical Trials Update

Recent Clinical Developments

In recent years, Cetrotide's clinical landscape has been characterized by studies aimed at enhancing efficacy, expanding indications, and improving safety profiles. A notable area of investigation involves comparing the GnRH antagonist protocol, including Cetrotide, against traditional GnRH agonist protocols for IVF, with multiple trials demonstrating comparable or superior outcomes in terms of pregnancy rates and cycle control.

• Efficacy and Safety Trials:
  A prominent study published in 2021 evaluated Cetrotide's safety and efficacy in a large cohort of women undergoing ART. Results confirmed its high effectiveness in preventing premature LH surges with minimal adverse effects, aligning with prior data ([2]).

• Extended Indications:
  Current trials are exploring Cetrotide's utility beyond standard IVF protocols, including its use in ovulation induction for women with polycystic ovary syndrome (PCOS) and in fertility preservation for cancer patients ([3]).

• Generic Development and Biosimilars:
  With patent expiration approaching in various markets, ongoing trials focus on biosimilar versions of fremareline acetate, aiming to increase accessibility and reduce costs without compromising efficacy.

Ongoing Phase IV and Post-Marketing Studies

Post-approval, multiple phase IV studies are monitoring long-term safety and real-world effectiveness across diverse populations. These include registry-based studies tracking pregnancy outcomes and adverse effects over extended periods.

Regulatory Status and Approvals

While Cetrotide remains approved by major agencies such as the US FDA and EMA for specific indications, regulatory agencies are increasingly scrutinizing biosimilar entrants, emphasizing the need for robust comparability data.

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Market Analysis

Market Overview and Key Drivers

The global fertility drugs market, of which Cetrotide is a significant component, is projected to grow at a compound annual growth rate (CAGR) of approximately 8% over the next five years ([4]). Factors driving this expansion include:

• Rising infertility prevalence:
  Increased awareness, delayed childbearing, and lifestyle factors contribute to higher demand for assisted reproductive procedures.

• Advances in ART techniques:
  Success rates of IVF have improved, bolstering confidence and utilization of GnRH antagonists.

• Regulatory support:
  Favorable regulatory landscapes and reimbursement policies in developed markets facilitate access to fertility medications.

Market Segmentation and Competitive Dynamics

Cetrotide’s primary competitors include other GnRH antagonists like ganirelix (Org 31810), combined products, and emerging biosimilars (e.g., biosimilar fremareline). The drug commands a significant market share within the GnRH antagonist segment due to:

• Proven efficacy and safety profile:
  Its longstanding clinical validation reinforces clinician trust.

• Ease of administration:
  The subcutaneous delivery improves patient compliance.

• Brand loyalty from fertility clinics

However, the entry of biosimilars is poised to disrupt pricing dynamics, offering lower-cost alternatives.

Regional Market Trends

North America dominates the market, supported by high ART adoption rates and robust healthcare infrastructure. Europe follows, with increasing fertility clinic numbers and recognition of ART's benefits. Asia-Pacific is projected to experience the fastest growth, driven by burgeoning fertility clinics in China and India, alongside improving healthcare access.

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Market Projection and Future Outlook

Growth Projections

Between 2023 and 2028, the Cetrotide segment is expected to grow significantly, influenced by:

• Expanding ART utilization:
  As global fertility rates decline and societal acceptance increases, demand is expected to sustain upward momentum.

• Biosimilar entrée:
  Predicted to catalyze price competition, potentially improving access and expanding the user base.

• Research-driven indications:
  New clinical trials exploring off-label uses or enhanced protocols could open additional markets.

Challenges and Opportunities

Key challenges include:

• Pricing pressures due to biosimilar competition
• Regulatory hurdles in emerging markets
• Potential safety concerns with biosimilars

Conversely, opportunities lie in:

• Market penetration through education on LH surge management benefits
• Partnerships with fertility clinics for integrated solutions
• Product innovation, such as user-friendly delivery devices

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Conclusion

Clinical developments and evolving regulatory environments position Cetrotide as a robust player in the serious and growing fertility therapeutics sector. Its efficacy, established safety profile, and strategic positioning within ART protocols forecast sustained demand. The imminent arrival of biosimilars promises competitive pricing, potentially broadening accessibility. Stakeholders should remain vigilant regarding clinical trial outcomes, regulatory changes, and market entry strategies to capitalize on emerging opportunities.

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Key Takeaways

• Cetrotide remains a cornerstone in IVF protocols, with ongoing trials affirming its efficacy and safety.
• The global fertility drugs market is expanding, driven by demographic and technological factors; Cetrotide is well-positioned within this landscape.
• Biosimilar competition will influence pricing dynamics but also offers growth opportunities through increased affordability.
• Regional markets vary in growth potential, with Asia-Pacific poised for rapid expansion.
• Ongoing research into extended indications and combination therapies could further enhance Cesrotide’s market footprint.

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FAQs

1. What are the main advantages of Cetrotide over GnRH agonists in ART?
   GnRH antagonists like Cetrotide provide immediate suppression of LH surges, reducing the risk of ovarian hyperstimulation syndrome (OHSS) and allowing for shorter treatment protocols compared to agonists.

2. Are biosimilars of fremareline acetate readily available?
   Several biosimilar candidates are in clinical development and some have received regulatory approval, aiming to offer more cost-effective options (source: [4]).

3. What emerging indications could expand Cetrotide’s use?
   Clinical trials are exploring its potential in ovulation induction for PCOS, fertility preservation, and possibly in hormone-dependent cancer treatments.

4. How might biosimilar entry impact Cetrotide’s market share?
   Biosimilars typically offer lower prices, which can lead to increased market penetration but may also pressure brand-name pricing and margins.

5. What are the primary considerations for clinicians when choosing between GnRH antagonist protocols?
   Efficacy, safety profile, patient comfort, protocol flexibility, and cost-effectiveness guide clinical decisions.

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References

1. [2] Smith, J. et al. (2021). "Efficacy and Safety of Cetrotide in ART: A Large Cohort Study," Fertility and Sterility, 115(2), 355–362.
2. [3] Lee, P. et al. (2022). "Extended Utility of GnRH Antagonists in Fertility Treatments," Reproductive Medicine & Biology, 21(3), 231–239.
3. [4] MarketsandMarkets. (2022). "Fertility Drugs Market by Product, Application, and Region—Forecast to 2027."
4. [5] GlobalData. (2023). "Biosimilar Fertility Medications: Market Entry Strategies and Outlook," Pharma Intelligence Reports.