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

Infertility Clinical Trial

Official title:

A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109654
• Other study ID #: EMR200088-500
• Status: Completed
• Phase: N/A
• First received: April 22, 2010
• Last updated: July 15, 2014
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Observational

Clinical Trial 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.

Description:

Gonadotrophin-releasing hormone (GnRH) antagonists were introduced in the beginning of this decade for the use in ART. The potential advantages of GnRH antagonists over the GnRH agonists include the avoidance of an acute stimulation of endogenous gonadotrophins and a dramatic reduction in the length of analogue treatment.

Despite the plus points of GnRH antagonists in ART, there has been some concern over the lower pregnancy rate reported, which may be the cause of a lower acceptance of GnRH antagonists in ovarian stimulation for in vitro fertilization (IVF). Interestingly, a separate meta-analysis did not reach the same finding. The probability of live birth after ovarian stimulation for IVF was found not to be dependent on the type of analogue used for pituitary suppression Cetrotide, a GnRH antagonist from Merck Serono, is currently approved for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation in majority of the regions. It is given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection. Both regimens have been shown to offer equivalent efficacy and safety outcomes.

OBJECTIVES:

Primary objective:

• To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles

Secondary objectives:

• To assess the effectiveness of Cetrotide regimens on other efficacy endpoints

• To survey the types of Cetrotide regimen used and their success rates

• To assess the safety of Cetrotide regimens

• To explore the association between subject characteristics and treatment outcomes

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2175
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Singapore	Singapore General Hospital Pte Ltd, Outram Road	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Pte. Ltd., Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of subjects with cancelled cycles		3 month	No
Secondary	Proportion of women with OHSS or risk of OHSS		3 month	Yes
Secondary	Duration and dose of Cetrotide administered		3 month	No
Secondary	Assessment of baseline characteristics	Assessment of subjects age, weight, height, FSH and LH level prior to Gonal-f administration, concomitant treatment, infertility history and infertility treatment	3 month	No
Secondary	Total dose of Gonal-f administered		3 month	No
Secondary	Duration of ovarian stimulation		3 month	No
Secondary	Number of oocytes retrieved		3 month	No
Secondary	Number of subjects with Adverse Events		3 month	Yes
Secondary	Pregnancy rate		12 month	No
Secondary	Live birth rate		12 month	No