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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
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Semra Kahraman, Memorial Sisli Hospital, Istanbul

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: oral estrogen replacement therapy Drug: Estradiol transdermal patch Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Turkey
Memorial Sisli Hospital ART and Genetics Center
Istanbul, Turkey
Sponsors and Collaborators
Memorial Sisli Hospital, Istanbul

Responsible Party: Prof. Dr. Semra Kahraman, Director of ART and Genetics Center of Memorial Sisli Hospital, Memorial Sisli Hospital, Istanbul
ClinicalTrials.gov Identifier: NCT03155048     History of Changes
Other Study ID Numbers: EndometrialpreparingSK002
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female