NCT01816321

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (\<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.

Detailed description

Recently, the European Society of Human Reproduction and Embryology developed a new definition in order to select patients suitable for inclusion in future clinical trials as poor ovarian responders, the so-called "Bologna criteria". However, a limited number of studies has been published to date including patients with poor ovarian response according to the "Bologna criteria", whereas no randomized trial is published or ongoing for this population. Preliminary reports in "Bologna poor responders" highlight the limited prospects for these women. Natural cycle IVF has been shown to result in disappointingly low live birth rates, regardless of patients' age and ovarian stimulation with widely accepted treatment modalities, e.g. short agonist protocol, did not appear demonstrate substantial benefits. Nonetheless, despite the disappointing results from the vast majority of the preliminary studies in this population, a recent pilot study by our group has shown that a specific protocol may indeed be a promising option for women of younger age fulfilling the "Bologna criteria". Corifollitropin alfa followed by highly purified hMG in an antagonist protocol demonstrated an ongoing pregnancy rate of 28% in women \<40years, strongly suggesting the conduction of a future randomized trial testing this novel treatment protocol

Conditions

• Infertility
• Poor Ovarian Response

Interventions

Type	Name	Description
DRUG	Corifollitropin alfa	Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)
DRUG	recombinant FSH	recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering
DRUG	Ganirelix	Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering
DRUG	hp HMG	hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-03-22
• Last updated: 2016-06-23

Locations

2 sites across 2 countries: Belgium, Vietnam