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Clinical Trials/NCT04733235
NCT04733235
Completed
Not Applicable

The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage

Akdeniz University1 site in 1 country205 target enrollmentJuly 1, 2020

Overview

Phase
Not Applicable
Intervention
Progesterone
Conditions
Infertility
Sponsor
Akdeniz University
Enrollment
205
Locations
1
Primary Endpoint
ongoing pregnancy rates.
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Detailed Description

For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET). A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness. Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
July 15, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ŞAFAK OLGAN

ASSOCIATE PROFESSOR

Akdeniz University

Eligibility Criteria

Inclusion Criteria

  • Woman aged 18-40 years
  • Presence of high quality (\>2BB) blastocyst
  • Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
  • presence of high quality blastocyst cryopreserved by vitrification method.
  • A single embryo transfer

Exclusion Criteria

  • Presence of uterine pathology
  • Participants whose optimal endometrial image cannot be obtained due to uterine position
  • Participants whose treatments were canceled for any reason before embryo transfer
  • Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
  • Participants who had 2 embryo transfer
  • Presence of low quality (\<2BB) blastocyst
  • \> 15% loss of viability in the embryo during embryo thawing

Arms & Interventions

with endometrial compaction

Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Intervention: Progesterone

without endometrial compaction

Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Intervention: Progesterone

Outcomes

Primary Outcomes

ongoing pregnancy rates.

Time Frame: 1 year

pregnancy beyond 12 weeks of gestational age.

The change in endometrial thickness

Time Frame: 1 year

changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Secondary Outcomes

  • Clinical pregnancy rate(6-7 weeks after the last menstrual period of the patient)
  • The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer(On the day of frozen embryo transfer)
  • Clinical miscarriage(after 5th gestational week)
  • Implantation rate(5 weeks after the last menstrual period of the patient)

Study Sites (1)

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