Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders
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 long GnRH agonist protocol.
Poor Ovarian Response
Drug: Corifollitropin alfa 150μg
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders|
- 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 oocyte retrieval [ 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 21 of the cycle onwardsDrug: Corifollitropin alfa 150μg
Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelinDrug: hpHMG
hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards
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 long GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"