An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)
|ClinicalTrials.gov Identifier: NCT01109654|
Recruitment Status : Completed
First Posted : April 23, 2010
Last Update Posted : July 16, 2014
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.
|Condition or disease||Intervention/treatment|
|Infertility||Drug: Cetrorelix acetate and Follitropin alfa|
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.
- To assess the effectiveness of Cetrotide regimens, when used with Gonal-f, in routine ART treatment cycles
- 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
|Study Type :||Observational|
|Actual Enrollment :||2175 participants|
|Official Title:||A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
- 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' discretionOther Names:
- Proportion of subjects achieving a clinical pregnancy. [ Time Frame: At post hCG days 35-42 ]A transvaginal ultrasound scan will be performed on all subjects who become pregnant provided that no miscarriage has occurred.
- Proportion of subjects with cancelled cycles [ Time Frame: 3 month ]
- Proportion of women with OHSS or risk of OHSS [ Time Frame: 3 month ]
- Duration and dose of Cetrotide administered [ Time Frame: 3 month ]
- Assessment of baseline characteristics [ Time Frame: 3 month ]Assessment of subjects age, weight, height, FSH and LH level prior to Gonal-f administration, concomitant treatment, infertility history and infertility treatment
- Total dose of Gonal-f administered [ Time Frame: 3 month ]
- Duration of ovarian stimulation [ Time Frame: 3 month ]
- Number of oocytes retrieved [ Time Frame: 3 month ]
- Number of subjects with Adverse Events [ Time Frame: 3 month ]
- Pregnancy rate [ Time Frame: 12 month ]
- Live birth rate [ Time Frame: 12 month ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109654
|Singapore General Hospital Pte Ltd, Outram Road|
|Singapore, Singapore, 609927|
|Study Director:||Medical Director||Merck Pte. Ltd., Singapore|