Estradiol administration for patients with a history of poor IVFresponse

Phase 2

Conditions: Female infertility.
Female infertility

Registration Number: IRCT201108044339N8

Lead Sponsor: Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences

Brief Summary: Purpose This study aims to verify if luteal estradiol pre-treatment improves IVF/ICSI outcomes in a GnRH antagonist protocol as compared with a micro dose GnRH agonist protocol in poor-responding patients. Methods A total of 116 IVF/ICSI cycles were included in this prospective randomized single blind clinical trial. The selected women were randomly assigned to receive an estradiol pre-treatment in a GnRH antagonist protocol (daily oral Estradiol Valerate 4 mg preceding the IVF cycle from the 21st day until the first day of the next cycle) or in oral contraceptive pill micro dose GnRH agonist protocol. Results The patients in the luteal estradiol protocol required more days of stimulation (10.9 ± 1.6 vs. 10.2 ± 1.8) and a greater gonadotropin requirement (3,247.8 ± 634.6 vs. 2,994.8 ± 611 IU), yet similar numbers of oocytes were retrieved and fertilized. There was no significant difference between the two groups in terms of the implantation rates (9.8 vs. 7.9 %) and the clinical pregnancy rates per transfer (16.3 vs. 15.6 %). Conclusion This study demonstrates that the use of estradiol during a preceding luteal phase in a GnRH antagonist protocol can provide similar IVF outcomes when compared to a micro dose GnRH agonist protocol.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Female

Target Recruitment: 116

Inclusion Criteria

A history of poor response in a prior cycle (=3 oocytes retrieved, poor-quality oocytes,
Cycle cancellation due to inadequate ovarian response
Women anticipated to be a poor responder based on initial testing (third-day FSH level of 10 mIU/mL, or a basal antral follicle count <5)

Exclusion Criteria

Stage III–IV endometriosis
Autoimmune or chromosomal disorders
Endocrine or metabolic diseases
Existence of only one ovary
Patients exhibiting a day 3 serum FSH level greater than 15 mIU/mL
Sever male factor (patients with azoospermia and normal morphology of sperm <4%)
Hydrosalpinx

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of oocyte retrival. Timepoint: Day of punctuer. Method of measurement: Counting by microscope.;Clinical pregnancy rates. Timepoint: 5 weeks after the embryo transfer. Method of measurement: Presence of a gestational sac with heart beat identified byultrasound.

Secondary Outcome Measures

Name	Time	Method
The cycle length. Timepoint: From the start of the drug until the day of the puncture. Method of measurement: Calendar.;The total dose of gonadotropin. Timepoint: From the start of the drug until the day of the puncture. Method of measurement: International unit.;The implantation rate. Timepoint: 5 weeks after the embryo transfer. Method of measurement: The number of pregnancy sacs divided by the number of transferred embryos multiplied by 100.