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The Effects of Estrogen on Artificial Endometrium

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
oral estrogen replacement therapy
Estradiol transdermal patch
Sponsored by
Memorial Sisli Hospital, Istanbul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All the women with at least one day 5 or 6 blastocyst
  • Appropriate endometrial thickness is more than 7 millimeters on the 14th day of artificial endometrial preparation cycle
  • Age under 38 years
  • Follicle stimulating hormone less than 12 IU/Liter
  • No more than 2 previous treatment cycles
  • No history of recurrent spontaneous abortions

Exclusion Criteria:

  • Polycystic ovarian syndrome (> 30 cumulus oocyte complexes retrieved at the pick-up)
  • Endocrine or metabolic disorder
  • Endometriosis
  • Embryos derived from donated gametes
  • Any underlying diseases (kidney, liver or heart diseases)
  • Bad-quality embryos
  • Uterine malformation
  • Endometrial polyp
  • Severe male factor (Azoospermia)
  • Body mass index more than 30
  • Thrombophilia

Sites / Locations

  • Memorial Sisli Hospital ART and Genetics Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

oral estradiol group

estradiol transdermal patch group

Arm Description

patients with the usage of 6 milligrams/day oral estradiol

patients with the usage of 3.9 milligrams estradiol transdermal patch

Outcomes

Primary Outcome Measures

Endometrial thickness on the day of progesterone administration
In frozen thawed embryo transfer cycles, endometrial preparation with estrogen was performed. Estrogen was applied from the second day of menstruation cycle to 11th day of cycle. Endometrial thickness was measured by transvaginal ultrasound. If endometrial thickness was more than 7 millimeters, endometrial thickness was ready for embryo transfer on the day of progesterone administration.

Secondary Outcome Measures

Implantation rate
The effects of transdermal estradiol and oral estradiol valerate on implantation rates were evaluated. Implantation rates are described as gestational sacs seen by transvaginal ultrasound per embryo transfer.

Full Information

First Posted
May 10, 2017
Last Updated
November 2, 2018
Sponsor
Memorial Sisli Hospital, Istanbul
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1. Study Identification

Unique Protocol Identification Number
NCT03155048
Brief Title
The Effects of Estrogen on Artificial Endometrium
Official Title
The Effects of Transdermal Estradiol and Oral Estradiol Valerate on Clinical Outcomes of Frozen-thawed Embryo Transfer Cycles: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial Sisli Hospital, Istanbul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch.
Detailed Description
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch. A total number of 317 patients who underwent frozen -thawed embryo transfer cycles were enrolled in this study and randomized to two groups including 160 patients with the usage of 6 milligrams/day oral estradiol and 154 patients with the usage of 3.9 milligrams estradiol transdermal patch. Randomization was done with http://www.randomization.com. The patients were given sufficient information to provide written informed consent. All the women underwent intracytoplasmic sperm injection (ICSI). Treatment protocols: All the patients selected for the research were primed for a frozen transfer using two different ways of exogenous steroid therapy. In the study group with transdermal route (n=154), 3.9 milligrams of estradiol transdermal patch was applied every other day from the second day of menstruation cycle, and each patch was removed after day. In the control group with oral route (n=160), at the time of cycle, 6 milligrams of oral estradiol valerate was started daily. In both groups, clinical monitoring was done by transvaginal ultrasound from the 11th day of the cycle to measure endometrial thickness. If endometrial thickness was more than 7 millimeter, 90 milligrams vaginal natural progesterone was added. Embryo transfer was done after 5 days. The primary outcome measure was endometrial thickness on the day of progesterone administration. The secondary outcome measures were chemical and clinical pregnancy, implantation rates, abortion rates, live birth rates, and cycle cancellation rate.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
317 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral estradiol group
Arm Type
Active Comparator
Arm Description
patients with the usage of 6 milligrams/day oral estradiol
Arm Title
estradiol transdermal patch group
Arm Type
Active Comparator
Arm Description
patients with the usage of 3.9 milligrams estradiol transdermal patch
Intervention Type
Drug
Intervention Name(s)
oral estrogen replacement therapy
Intervention Description
oral estradiol group for endometrial preparation
Intervention Type
Drug
Intervention Name(s)
Estradiol transdermal patch
Intervention Description
transdermal estradiol group for endometrial preparation
Primary Outcome Measure Information:
Title
Endometrial thickness on the day of progesterone administration
Description
In frozen thawed embryo transfer cycles, endometrial preparation with estrogen was performed. Estrogen was applied from the second day of menstruation cycle to 11th day of cycle. Endometrial thickness was measured by transvaginal ultrasound. If endometrial thickness was more than 7 millimeters, endometrial thickness was ready for embryo transfer on the day of progesterone administration.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Implantation rate
Description
The effects of transdermal estradiol and oral estradiol valerate on implantation rates were evaluated. Implantation rates are described as gestational sacs seen by transvaginal ultrasound per embryo transfer.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Clinical Pregnancy rate
Description
The effects of transdermal estradiol and oral estradiol valerate on clinical pregnancy rate were evaluated. Clinical pregnancy rate is measured with a pregnancy where an ultrasound scan has shown at least one fetal heartbeat per embryo transfer.
Time Frame
12 months
Title
Live birth rate
Description
The effects of transdermal estradiol and oral estradiol valerate on live birth rate were evaluated. Live birth rate is described as live birth per embryo transfer.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All the women with at least one day 5 or 6 blastocyst Appropriate endometrial thickness is more than 7 millimeters on the 14th day of artificial endometrial preparation cycle Age under 38 years Follicle stimulating hormone less than 12 IU/Liter No more than 2 previous treatment cycles No history of recurrent spontaneous abortions Exclusion Criteria: Polycystic ovarian syndrome (> 30 cumulus oocyte complexes retrieved at the pick-up) Endocrine or metabolic disorder Endometriosis Embryos derived from donated gametes Any underlying diseases (kidney, liver or heart diseases) Bad-quality embryos Uterine malformation Endometrial polyp Severe male factor (Azoospermia) Body mass index more than 30 Thrombophilia
Facility Information:
Facility Name
Memorial Sisli Hospital ART and Genetics Center
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effects of Estrogen on Artificial Endometrium

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