Pretreatment With Estradiol Valerate

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Estradiol valerate

• Registration Number: NCT01218386
• Lead Sponsor: Universitair Ziekenhuis Brussel

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

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-08
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-27
• Last Update Posted: 2012-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Estradiol valerate	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
Control group	Estradiol valerate	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

Primary Outcome Measures

Name	Time	Method
number of egg retrievals on weekend days	up to 9 months

Secondary Outcome Measures

Name	Time	Method
The mean number of coc in each treatment group	up to 9 months

Trial Locations

Locations (1)

UZ Brussel, Centre for Reproductive Medicine; 🇧🇪 Brussel, Belgium