The Effects of Estrogen on Artificial Endometrium
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

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.
    

Intervention name(s): oral estrogen replacement therapy; Estradiol transdermal patch
Intervention type(s): Drug; Drug
Intervention description(s): oral estradiol group for endometrial preparation; transdermal estradiol group for endometrial preparation
Intervention MeSH terms: Estradiol; Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment