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Completed

NCT Number: NCT01367912

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

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).

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zekai Tahir Burak Maternity and Teaching Hospital

Ankara, 06220, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

estradiol tablet

Drug

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

Other names: estrofem 2 mg tablet, Novo Nordisk, Bagsvaerd, Denmark

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: sixth gestational week.

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

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Timing of Estrogen Support During the Luteal Phase of IVF / Intracytoplasmic Sperm Injection Cycle: a Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 7, 2011
Registry last updated
Jun 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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