The Effects of Estrogen on Artificial Endometrium
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|ClinicalTrials.gov Identifier: NCT03155048|
Recruitment Status : Completed
First Posted : May 16, 2017
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: oral estrogen replacement therapy Drug: Estradiol transdermal patch||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||317 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Transdermal Estradiol and Oral Estradiol Valerate on Clinical Outcomes of Frozen-thawed Embryo Transfer Cycles: A Randomized Clinical Trial|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||October 1, 2017|
|Actual Study Completion Date :||September 1, 2018|
Active Comparator: oral estradiol group
patients with the usage of 6 milligrams/day oral estradiol
Drug: oral estrogen replacement therapy
oral estradiol group for endometrial preparation
Active Comparator: estradiol transdermal patch group
patients with the usage of 3.9 milligrams estradiol transdermal patch
Drug: Estradiol transdermal patch
transdermal estradiol group for endometrial preparation
- Endometrial thickness on the day of progesterone administration [ Time Frame: 6 months ]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.
- Implantation rate [ Time Frame: 12 months ]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.
- Clinical Pregnancy rate [ Time Frame: 12 months ]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.
- Live birth rate [ Time Frame: 12 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03155048
|Memorial Sisli Hospital ART and Genetics Center|