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

This study has been completed.
Sponsor:
Information provided by:
Zekai Tahir Burak Maternity and Teaching Hospital
ClinicalTrials.gov Identifier:
NCT01367912
First received: June 3, 2011
Last updated: June 6, 2011
Last verified: November 2008
History of Changes
  Purpose

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).


Condition Intervention
Infertility
 Drug: estradiol tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Timing of Estrogen Support During the Luteal Phase of IVF / Intracytoplasmic Sperm Injection Cycle: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Zekai Tahir Burak Maternity and Teaching Hospital:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: sixth gestational week. ] [ Designated as safety issue: No ]
    Clinical pregnancies were detected with the confirmation of positive fetal cardiac activities by transvaginal sonography in the sixth gestational week.


Enrollment: 301
Study Start Date: February 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Progesterone only group
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
Active Comparator: Progesterone+Early Estradiol group
received 2 mg estradiol tablets orally two times daily beginning from the first day after hCG injection, in addition to vaginal progesterone gel
 Drug: 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
Other Name: estrofem 2 mg tablet, Novo Nordisk, Bagsvaerd, Denmark
Active Comparator: Progesterone+Late estradiol group
received 2 mg estradiol tablets orally two times daily beginning from the fifth day after hCG injection, in addition to vaginal progesterone gel
 Drug: 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.
Other Name: estrofem 2 mg tablet, Novo Nordisk, Bagsvaerd, Denmark

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.

  Eligibility

Ages Eligible for Study:   up to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367912

Locations
Turkey
Zekai Tahir Burak Maternity and Teaching Hospital
Ankara, Turkey, 06220
Sponsors and Collaborators
Zekai Tahir Burak Maternity and Teaching Hospital
Investigators
Study Director: Leyla Mollamahmutoğlu, MD Zekai Tahir Burak Maternity and Teaching Hospital
  More Information

Publications:
Pouly JL, Piekrishvili R, Beaume-BrugonF, Schubert B, Janny L. Luteal phase supplementation with oestrogens doesn't improve the IVF pregnancy rate: a randomized study. Hum Reprod 2005; 20:O- 195.
Tonguc E, Var T, Ozyer S, Citil A, Dogan M. Estradiol supplementation during the luteal phase of in vitro fertilization cycles: a prospective randomized study. Eur J Obstet Gynecol Reprod Biol 2011; 154:172-76.
Causio F, Leonetti T. Luteal phase support with estrogen and progesterone in in vitro fertilization cycles using GnRHa and FSH. Gior Ital Ostet Ginecol 1997; 19: 277-82.
Elnashar AM, Aboul-Enein GI. Endometrial receptivity. Middle East Fertil Soc J 2004; 9 (1): 10-24).

Responsible Party: Institutional review board, Zekai Tahir Burak Maternity and Teaching Hospital, Murat ÖZEL, M.D.
ClinicalTrials.gov Identifier: NCT01367912     History of Changes
Other Study ID Numbers: ZTB
Study First Received: June 3, 2011
Last Updated: June 6, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Zekai Tahir Burak Maternity and Teaching Hospital:
Luteal phase support
estradiol supplementation
IVF/ICSI
clinical pregnancy rate

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estrogens
Progesterone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on May 16, 2013