Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
317 participants
INTERVENTIONAL
2017-05-01
2018-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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oral estradiol group
patients with the usage of 6 milligrams/day oral estradiol
oral estrogen replacement therapy
oral estradiol group for endometrial preparation
estradiol transdermal patch group
patients with the usage of 3.9 milligrams estradiol transdermal patch
Estradiol transdermal patch
transdermal estradiol group for endometrial preparation
Interventions
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oral estrogen replacement therapy
oral estradiol group for endometrial preparation
Estradiol transdermal patch
transdermal estradiol group for endometrial preparation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
38 Years
FEMALE
No
Sponsors
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Memorial Sisli Hospital, Istanbul
OTHER
Responsible Party
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Prof. Dr. Semra Kahraman
Director of ART and Genetics Center of Memorial Sisli Hospital
Locations
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Memorial Sisli Hospital ART and Genetics Center
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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EndometrialpreparingSK002
Identifier Type: -
Identifier Source: org_study_id
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