Infertility Clinical Trial
Official title:
A Prospective, Observational Study on the Use of Cetrotide (GnRH Antagonist) With GONAL-f in Assisted Reproductive Technologies (ART)
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.
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
;
Observational Model: Case-Only, Time Perspective: Prospective
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