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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status

Completed

Conditions

Infertility

Treatments

Drug: estradiol tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT01367912

ZTB

Details and patient eligibility

About

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).

Full 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.

Enrollment

301 patients

Sex

Female

Ages

Under 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

301 participants in 3 patient groups

Progesterone only group

No Intervention group

Description:

received a single daily application of vaginal progesterone gel beginning from the day of OPU and continued at least until pregnancy was ruled out by a negative serum ß-hCG measurement performed on the 14th day after embryo transfer with no E2 added

Progesterone+Early Estradiol group

Active Comparator group

Description:

received 2 mg estradiol tablets orally two times daily beginning from the first day after hCG injection, in addition to vaginal progesterone gel

Treatment:

Drug: estradiol tablet

Progesterone+Late estradiol group

Active Comparator group

Description:

received 2 mg estradiol tablets orally two times daily beginning from the fifth day after hCG injection, in addition to vaginal progesterone gel

Treatment:

Drug: estradiol tablet