Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial
- Conditions
- Poor Ovarian ResponseInfertility
- Interventions
- Registration Number
- NCT01816321
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- Age less than 40 years
- Fulfillment of the "Bologna criteria" for poor ovarian response.
Based on inclusion criteria two patients' categories are eligible:
- Women < 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle count <7 or antimullerian hormone serum values <1.1 ng/ml)
- Women <40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian stimulation
In addition women less than 40 years old will be considered eligible if they had undergone previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have an AMH<1.1ng/ml or an AFC<7, as suggested by the Bologna criteria
- Uterine abnormalities
- Recent history of any current untreated endocrine abnormality
- Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped)
- Contraindications for the use of gonadotropins
- Recent history of severe disease requiring regular treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Corifollitropin alfa followed by hpHMG Ganirelix - Corifollitropin alfa followed by hpHMG hp HMG - recombinant FSH recombinant FSH - Corifollitropin alfa followed by hpHMG Corifollitropin alfa - recombinant FSH Ganirelix -
- Primary Outcome Measures
Name Time Method Ongoing pregnancy 9-10 weeks of gestation The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation.
- Secondary Outcome Measures
Name Time Method Clinical pregnancy 7 weeks of gestation The presence of intrauterine gestational sac at 7 weeks of gestation
Biochemical pregnancy 2 weeks after embryo transfer Positive pregnancy test 2 weeks after embryo transfer
Number of oocytes retrieved 9 -20 days from initiation of ovarian stimulation The outcome will be evaluated on the day of oocyte retrieval
Trial Locations
- Locations (2)
Universitair Ziekenhuis Brussel
🇧🇪Brussels, Belgium
University of Medicine and Pharmacy of Ho Chi Minh City
🇻🇳Ho Chi Minh City, Vietnam