The Effects of Estrogen on Artificial Endometrium

NCT03155048 | Completed DMC

• 1 other identifier: EndometrialpreparingSK002
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Implantation rate

  12 months

Other Outcomes (2)

• Clinical Pregnancy rate

  12 months

• Live birth rate

  12 months

Study Arms (2)

oral estradiol group

ACTIVE COMPARATOR

patients with the usage of 6 milligrams/day oral estradiol

Drug: oral estrogen replacement therapy

estradiol transdermal patch group

ACTIVE COMPARATOR

patients with the usage of 3.9 milligrams estradiol transdermal patch

Drug: Estradiol transdermal patch

Interventions

oral estrogen replacement therapy DRUG

oral estradiol group for endometrial preparation

oral estradiol group

Estradiol transdermal patch DRUG

transdermal estradiol group for endometrial preparation

estradiol transdermal patch group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sisli Hospital, Istanbul: lead

Study Sites (1)

Memorial Sisli Hospital ART and Genetics Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Estrogen Replacement Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Replacement Therapy; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of ART and Genetics Center of Memorial Sisli Hospital

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 16, 2017
• Study Start: May 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: September 1, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)