Infertility Clinical Trial
Official title:
The Effects of Transdermal Estradiol and Oral Estradiol Valerate on Clinical Outcomes of Frozen-thawed Embryo Transfer Cycles: A Randomized Clinical Trial
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.
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.
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