NCT01732068

Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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"

Conditions

• Infertility
• Poor Ovarian Response

Interventions

Type	Name	Description
DRUG	Triptorelin	Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
DRUG	Corifollitropin alfa	Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
DRUG	hpHMG	300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-11-22
• Last updated: 2013-05-09

Locations

1 site across 1 country: Belgium