Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696) (Xpect)
|ClinicalTrials.gov Identifier: NCT00778999|
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : August 12, 2009
Last Update Posted : May 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Marvelon||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||442 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label Clinical Trial to Identify Predictive Factors for Controlled Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH in GnRH Antagonist Regimen With or Without Oral Contraceptive Scheduling|
|Actual Study Start Date :||October 1, 2006|
|Primary Completion Date :||July 24, 2008|
|Study Completion Date :||July 24, 2008|
Active Comparator: Oral Contraceptive
Use of oral contraceptive pills prior to controlled ovarian stimulation
oral contraceptive 1 tablet daily for 14 to 21 days
No Intervention: Non-Oral Contraceptive
No use of oral contraceptive pills prior to controlled ovarian stimulation
- Total Number of Oocytes [ Time Frame: 12 weeks ]The total number of oocytes on the Day of oocyte pick-up is an indication of ovarian response
- Number of Mature Oocytes [ Time Frame: 12 weeks ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
- Number of Follicles on Stimulation Day 8 [ Time Frame: 12 weeks ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
- Number of Follicles on Day of hCG [ Time Frame: 12 weeks ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
- Number of Fertilized (2PN) Oocytes [ Time Frame: 12 weeks ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.
- Number of Good Quality Embryos [ Time Frame: 12 weeks ]This is not a prespecified key secondary outcome; therefore, results will not be disclosed.