A Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in Women Undergoing Ovarian Stimulation

This study has been completed.

Sponsor:

Information provided by:

EMD Serono

ClinicalTrials.gov Identifier:

NCT00298025

First received: February 27, 2006

Last updated: March 21, 2009

Last verified: March 2009

History of Changes

Purpose

To demonstrate the comparative safety and efficacy of Cetrotide® 3 mg and Antagon™ in the inhibition of a premature LH surge in women undergoing ovarian stimulation with r hFSH/hMG prior to ART and utilizing oral contraceptives for cycle programming.

Condition	Intervention	Phase
Infertile Women Undergoing Assisted Reproductive Technology (ART)	Drug: Cetrotide® or Antagon ™	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Infertility

Drug Information available for: Cetrorelix Ganirelix Ganirelix acetate Cetrorelix acetate

U.S. FDA Resources

Further study details as provided by EMD Serono:

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Female

Criteria

Inclusion Criteria:

Premenopausal infertile women wishing to conceive, aged 18 39 years inclusive, regular menstrual cycles (generally 25 35 days in length) and screening early follicular phase FSH within normal limits

Exclusion Criteria:

Clinically significant systemic disease; any contraindication to pregnancy or carrying pregnancy to term; known ASRM Grade III or IV endometriosis; clinically significant abnormal findings on a transvaginal ultrasound within 6 weeks prior to the beginning of oral contraceptive (OCP) treatment; extrauterine pregnancy within 3 months prior to the beginning of OCP treatment; poor response in a previous ART cycle (≤ 3 oocytes retrieved); ≥ 3 prior, initiated, consecutive ART cycles without a clinical pregnancy; prior severe OHSS

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298025

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Eduardo Kelly, MD, MBA

EMD Serono

More Information

Additional Information:

Study published in Fertility & Sterility 84(1):108-17;2005 This link exits the ClinicalTrials.gov site

Full FDA approved prescribing information can be found here This link exits the ClinicalTrials.gov site

Publications:

Wilcox J, Potter D, Moore M, Ferrande L, Kelly E; CAP IV Investigator Group. Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies. Fertil Steril. 2005 Jul;84(1):108-17.

ClinicalTrials.gov Identifier:	NCT00298025 History of Changes
Other Study ID Numbers:	24688
Study First Received:	February 27, 2006
Last Updated:	March 21, 2009
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Infertility
Genital Diseases, Male
Genital Diseases, Female
Ganirelix
Cetrorelix

Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013

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