An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region. The study plans to enrol approximately 1800-2000 subjects over a 9-month period at each participating centre.

This observational study is initiated to collect information on the use of Cetrotide (GnRH antagonist) in ART cycles in routine practice across the Asia-Pacific region. The information will allow a better understanding of the current ovarian stimulation regimens that involve Cetrotide in the control of the endogenous gonadotrophin concentrations. The collection of live birth data, though a challenging task, as a secondary endpoint will allow the study to show valuable information on the final objective of ART. To minimize the potential variability due to the different ovarian stimulation agents, the study is to include cycles treated with Gonal-f (recombinant human FSH) since this agent is widely available in the region.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Pte. Ltd., Singapore
• Treatments: Cetrorelix; Follicle Stimulating Hormone; Hormone Antagonists

Criteria

Inclusion Criteria:

• Subjects who are undergoing ovarian stimulation for IVF or ICSI therapy

• Decision by treating physician to prescribe Gonal-f for controlled ovarian stimulation prior to study enrolment

• Decision by treating physician to prescribe Cetrotide as the down-regulation agent prior to study enrolment

Exclusion Criteria:

• Subjects using GnRH agonist as the down-regulation agent

• Contraindicated use of Cetrotide based on local label

• Subjects who have participated in the study previously

• Subjects with hypersensitivity to cetrorelix acetate, extrinsic peptide hormones or mannitol

• Subjects with known hypersensitivity to GnRH or any other GnRH analogs

• Subjects with known or suspected pregnancy, and lactation