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

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

estradiol tablet

About this trial

This is an interventional treatment trial for Infertility focused on measuring Luteal phase support, estradiol supplementation, IVF/ICSI, clinical pregnancy rate

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

Zekai Tahir Burak Maternity and Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Arm Label

Progesterone only group

Progesterone+Early Estradiol group

Progesterone+Late estradiol group

Arm 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

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

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

Outcomes

Primary Outcome Measures

Clinical pregnancy rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01367912

First Posted

June 3, 2011

Last Updated

June 6, 2011

Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01367912

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2008

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Luteal phase support, estradiol supplementation, IVF/ICSI, clinical pregnancy rate

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Progesterone only group

Arm Type

No Intervention

Arm Description

Arm Title

Progesterone+Early Estradiol group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Progesterone+Late estradiol group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

estradiol tablet

Other Intervention Name(s)

estrofem 2 mg tablet, Novo Nordisk, Bagsvaerd, Denmark

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

estradiol tablet

Other Intervention Name(s)

estrofem 2 mg tablet, Novo Nordisk, Bagsvaerd, Denmark

Intervention Description

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 Measure Information:

Title

Clinical pregnancy rate

Description

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

Time Frame

sixth gestational week.

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leyla Mollamahmutoğlu, MD

Organizational Affiliation

Zekai Tahir Burak Women's Health Research and Education Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Zekai Tahir Burak Maternity and Teaching Hospital

City

Ankara

ZIP/Postal Code

06220

Country

Turkey

12. IPD Sharing Statement

Citations:

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Citation

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Learn more about this trial

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

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