Follicular Phase Endocrine Characteristics During Ovarian Stimulation and GnRH Antagonist Co-treatment for IVF; Randomized Trial Comparing Corifollitropin Alfa (Elonva) Initiated on Cycle Day 2 or 4.
Overview
- Phase
- Phase 4
- Intervention
- corifollitropin alfa
- Conditions
- Infertility
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Consumption of rFSH at the end of the follicular phase
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of the present study is to analyse if corifollitropin alfa, an agent for prolonged ovarian stimulation, administered from day 4 can be clinically used instead of day 2 onwards for a controlled ovarian hyperstimulation (COH) in an antagonist protocol.
Detailed Description
Corifollitropin alfa is a new recombinant gonadotrophin with sustained follicle-stimulating activity. It offers novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF or in vitro fertilisation resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. Normally, this medication is started on day 2 of the cycle. In the present randomised trial, we want to evaluate whether this agent can be clinically used when started on day 4 of the cycle.
Investigators
Blockeel Christophe
MD, PhD
Universitair Ziekenhuis Brussel
Eligibility Criteria
Inclusion Criteria
- •\< 36 years old on day of randomisation
- •FSH \< 12 (in the early follicular phase)
- •Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.
- •Regular menstrual cycles of 21-35 days, presumed to be ovulatory.
- •Weight \> 60 kg
- •\< 3 previous trials
- •Randomisation at out-patient clinic
Exclusion Criteria
- •≥ 36 years old on day of randomisation
- •Endometriosis ≥ grade 3
- •Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle)
- •Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Arms & Interventions
Day 2 group
Patients undergo a standard treatment with a classical start of corifollitropin alfa in a GnRH antagonist protocol.
Intervention: corifollitropin alfa
Day 4 group
Patients undergo an ovarian stimulation, but start on day 4 with corifollitropin alfa
Intervention: corifollitropin alfa
Outcomes
Primary Outcomes
Consumption of rFSH at the end of the follicular phase
Time Frame: up to 9 months
The purpose is to assess the additional need for recFSH in each treatment group
Secondary Outcomes
- Pregnancy rate(Up to 9 months)