Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
Status:
Completed
Trial end date:
2008-07-24
Target enrollment:
Participant gender:
Summary
The success of assisted reproductive technologies (ART) is critically dependent on optimizing
protocols for controlled ovarian stimulation to provide adequate numbers of good quality
oocytes and embryos. This optimization is mainly valuable to a group of infertility patients
(9%-24%) who respond poorly to Controlled Ovarian Stimulation(COS). It is also important for
an additional 2.6% of the infertility patients who manifest a high response to gonadotropin
and are at risk for hyperstimulation syndrome, a life-threatening situation. Extensive
research was carried out and led to the introduction of GnRH antagonist, as an alternative to
Gonadotropin Releasing Hormone (GnRH) agonist, for the prevention of premature Luteinizing
Hormone (LH) surges. Further research to optimize the GnRH antagonist regimen concluded that
a daily treatment with 200 IU of recombinant Follicle Stimulating Hormone (recFSH) in a GnRH
antagonist regimen is safe, well tolerated and results in a good clinical outcome. This
protocol is now frequently applied in the US and Europe.
Predicting a woman's response (based on the assessment of ovarian reserve) to COS is useful
in determining individualized clinical management strategies for low and high responders and
thus avoiding cancellation. Such prediction when based on reliable scientific evidence is
valuable in consulting patients about their chances of success. A large number of studies
have been performed, which used certain clinical, ultrasonographic and hormonal markers
(called predictive factors), to try to optimize a COS protocol for patients who were
down-regulated with a long GnRH agonist protocol. Prospective trials of predictive models
have also been used to adjust the starting dose of FSH to prevent a too low or too high
ovarian response. To date, however, none have been performed for women undergoing ovarian
stimulation with a GnRH antagonist protocol.
The primary objective of this randomized, open-label, multicenter clinical trial was to
identify one or more factors capable of predicting ovarian response in women treated with a
daily dose of 200 IU recFSH in a GnRH antagonist protocol. Since many ART centers now use
oral contraceptives as a means to schedule patients stimulated with recFSH and a GnRH
antagonist for assisted reproduction, the trial evaluated also whether intervention with oral
contraceptives affects the accuracy of predictive models for ovarian response.