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Corifollitropin Alfa Followed by Hp-HMG Versus Recombinant FSH in Young Poor Ovarian Responders. A Multicentre Randomized Controlled Clinical Trial
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.
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
Age
18 - 39 years
Sex
FEMALE
Healthy Volunteers
No
Universitair Ziekenhuis Brussel
Brussels, Belgium
University of Medicine and Pharmacy of Ho Chi Minh City
Ho Chi Minh City, Vietnam
Start Date
March 1, 2013
Primary Completion Date
May 1, 2016
Completion Date
May 1, 2016
Last Updated
June 23, 2016
150
ACTUAL participants
Corifollitropin alfa
DRUG
recombinant FSH
DRUG
Ganirelix
DRUG
hp HMG
DRUG
Lead Sponsor
Universitair Ziekenhuis Brussel
Collaborators
NCT06826365
NCT07153367
Data Source & Attribution
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