Clinical trial NCT01109654: An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)
Official title: A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: Fertilization in Vitro
Reproductive Techniques, Assisted
Follicle Stimulating Hormone
Cetrotide
Gonal-f
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Pte. Ltd., Singapore
First posted: 2010-04-23
Enrollment: 2175
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects undergoing controlled ovarian stimulation.

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.

Detailed 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

Eligibility 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

Primary outcomes:
measure: Proportion of subjects achieving a clinical pregnancy.
timeFrame: At post hCG days 35-42
Secondary outcomes:
measure: Proportion of subjects with cancelled cycles
timeFrame: 3 month
measure: Proportion of women with OHSS or risk of OHSS
timeFrame: 3 month
measure: Duration and dose of Cetrotide administered
timeFrame: 3 month
measure: Assessment of baseline characteristics
timeFrame: 3 month
measure: Total dose of Gonal-f administered
timeFrame: 3 month
measure: Duration of ovarian stimulation
timeFrame: 3 month
measure: Number of oocytes retrieved
timeFrame: 3 month
measure: Number of subjects with Adverse Events
timeFrame: 3 month
measure: Pregnancy rate
timeFrame: 12 month
measure: Live birth rate
timeFrame: 12 month
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital Pte Ltd, Outram Road
Study officials:
affiliation: Merck Pte. Ltd., Singapore
name: Medical Director
role: STUDY_DIRECTOR
References: