Pretreatment With Estradiol Valerate

Study Overview
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Brief Summary
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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
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See Section Interventions

Official Title
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Programmation of GnRH Antagonist Cycles With Estradiol Valerate: Impact on the Stimulation in IVF/ICSI.

Conditions
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Infertility

Intervention / Treatment
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* Drug: Estradiol valerate


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>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 | Drug: Estradiol valerate<br>* Experimental group: 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. Both groups:start rFSH (Puregon®) at a dose of 150 IU GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation.<br>* Other names: Progynova;|
| Active Comparator: Control group<br>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 | Drug: Estradiol valerate<br>* Experimental group: 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. Both groups:start rFSH (Puregon®) at a dose of 150 IU GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation.<br>* Other names: Progynova;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of egg retrievals on weekend days |  | up to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean number of coc in each treatment group |  | up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICSI, GnRH antagonists, planning