Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Drug: estradiol tablet

• Registration Number: NCT01367912
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).

Detailed Description

Several studies reported that elevated E2 may have a detrimental effect on endometrial receptivity and embryo. This conflict was the starting point of our study. The investigators thought that this luteal decrease in E2 level could be prevented by adding estradiol just before the receptivity window is open, instead of adding earlier in the luteal phase which could result in defective embryo implantation.

Study Timeline

• Study Start: 2008-02
• Status Verified: 2008-11
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-06
• Last Update Submitted: 2011-06-06
• Study First Posted: 2011-06-07
• Last Update Posted: 2011-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 301

Inclusion Criteria

• All patients on long GnRH agonist protocol with controlled ovarian hyperstimulation who were seen in our IVF clinic between February and November 2008, and who have E2 levels on the day of hCG administration >2500 pg/dl

Exclusion Criteria

• Presence of azoospermia requiring testicular sperm extraction procedure
• endometriosis greater than stage II
• unilateral oophorectomy, polycystic ovarian syndrome (PCOS)
• secondary infertility
• age greater than 40 yrs and a basal follicle stimulating hormone (FSH) level higher than 12 mIU/ml were exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone+Early Estradiol group	estradiol tablet	received 2 mg estradiol tablets orally two times daily beginning from the first day after hCG injection, in addition to vaginal progesterone gel
Progesterone+Late estradiol group	estradiol tablet	received 2 mg estradiol tablets orally two times daily beginning from the fifth day after hCG injection, in addition to vaginal progesterone gel

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	sixth gestational week.	Clinical pregnancies were detected with the confirmation of positive fetal cardiac activities by transvaginal sonography in the sixth gestational week.

Trial Locations

Locations (1)

Zekai Tahir Burak Maternity and Teaching Hospital; 🇹🇷 Ankara, Turkey