Programmation of GnRH Antagonist Cycles With Estradiol Valerate: Impact on the Stimulation in IVF/ICSI.
Overview
- Phase
- Phase 4
- Intervention
- Estradiol valerate
- Conditions
- Infertility
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- number of egg retrievals on weekend days
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The present study is set up to evaluate the efficacy of a programmation by administration of estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days during the luteo-follicular transition period of the menstrual cycle.
Detailed Description
See Section Interventions
Investigators
Blockeel Christophe
Dr
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. BMI between 18 and 29 (both inclusive) 1st or 2nd trial IVF or ICSI
Exclusion Criteria
- •≥ 36 years old on day of randomisation Endometriosis ≥ grade 3 PCOS Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle) Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)
Arms & Interventions
Study Group
Start with estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards. If day 25 is Monday: 6 days Tuesday: 10 days Wednesday: 9 days Thursday: 8 days Friday: 7 days Saturday: 6 days Sunday: 6 days of Progynova, 2x2 mg per day After this pretreatment: Standard GnRH antagonist treatment protocol with start rFSH (Puregon®) at a dose of 150 IU From day 2 of the cycle onwards; GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation
Intervention: Estradiol valerate
Control group
Standard GnRH antagonist treatment protocol with start rFSH (Puregon®) at a dose of 150 IU From day 2 of the cycle onwards; GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation
Intervention: Estradiol valerate
Outcomes
Primary Outcomes
number of egg retrievals on weekend days
Time Frame: up to 9 months
Secondary Outcomes
- The mean number of coc in each treatment group(up to 9 months)