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
Verified date | November 2018 |
Source | Memorial Sisli Hospital, Istanbul |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 317 |
Est. completion date | September 1, 2018 |
Est. primary completion date | October 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Memorial Sisli Hospital ART and Genetics Center | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Memorial Sisli Hospital, Istanbul |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical Pregnancy rate | 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. | 12 months | |
Other | Live birth rate | 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. | 12 months | |
Primary | 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. | 6 months | |
Secondary | 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. | 12 months |
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