A Phase 4 interventional study of Estradiol valerate in Infertility, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2012-03-28.
Sponsored by Universitair Ziekenhuis Brussel · Phase 4, Interventional, and Treatment
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
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 80 is below the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.
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\< 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)
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
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
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.
Also known as: Progynova
number of egg retrievals on weekend days
Time frame: up to 9 months
The mean number of coc in each treatment group
Time frame: up to 9 months
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Universitair Ziekenhuis Brussel