Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.
Poor Ovarian Response
Drug: Corifollitropin alfa
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol|
- Ongoing pregnancy rate [ Time Frame: 10 to 12 weeks of gestation ] [ Designated as safety issue: No ]
- Number of oocytes retrieved [ Time Frame: Day of oocyte retrieval ] [ Designated as safety issue: No ]
- Cycles with embryo transfer [ Time Frame: Day of Embryo transfer ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: Corifollitropin alfa+hMG||
Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwardsDrug: Corifollitropin alfa
Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycleDrug: hpHMG
300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.
In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"