Pretreatment With Estradiol Valerate

Universitair Ziekenhuis Brussel80 enrolled

Overview

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.

See Section Interventions

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Infertility

Interventions

Estradiol valerateDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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)

Locations (1)

UZ Brussel, Centre for Reproductive Medicine

Brussels, Belgium

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

Time frame: up to 9 months

Data from ClinicalTrials.gov

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