MedTrace Logo

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

NCT01109654 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2175

Last updated 2014-07-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cetrorelix acetate and Follitropin alfa

Cetrorelix acetate given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection.Ovarian stimulation therapy with Follitropin alfa generally starts on cycle Day 2 or 3. The starting dose of Follitropin alfa is based on the Investigators' discretion

Sponsors & Collaborators

  • Merck Pte. Ltd., Singapore

    collaborator INDUSTRY

  • Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Pte. Ltd., Singapore

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109654 on ClinicalTrials.gov