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

NCT01109654 | Completed

• 1 other identifier: EMR200088-500
• Study Type: observational
• Target: 2,175
• Locations: 1 country
• Sites: 1

Brief 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

Infertility

Keywords

Fertilization in Vitro; Reproductive Techniques, Assisted; Follicle Stimulating Hormone; Cetrotide; Gonal-f

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving a clinical pregnancy.

  A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.

  At post hCG days 35-42

Secondary Outcomes (10)

• Proportion of subjects with cancelled cycles

  3 month

• Proportion of women with OHSS or risk of OHSS

  3 month

• Duration and dose of Cetrotide administered

  3 month

• Assessment of baseline characteristics

  3 month

• Total dose of Gonal-f administered

  3 month

Interventions

Cetrorelix acetate and Follitropin alfa DRUG

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

Also known as: Cetrotide, Gonal-f

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female subjects undergoing controlled ovarian stimulation.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Pte. Ltd., Singapore: collaborator

Study Sites (1)

Singapore General Hospital Pte Ltd, Outram Road

Singapore, 609927, Singapore

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, Serum, Tissue, Urine

MeSH Terms

Conditions

Infertility; Helping Behavior

Interventions

cetrorelix; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Social Behavior; Behavior

Study Officials

• Medical Director

  Merck Pte. Ltd., Singapore

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 16, 2014

Record last verified: 2012-01

Locations

SG (1)