the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes

December 29, 2022 updated by: ŞAFAK OLGAN, Akdeniz University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Actual)

205

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Antalya, Turkey
        • Akdeniz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women underwent frozen embryo transfer

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Presence of uterine pathology
  2. Participants whose optimal endometrial image cannot be obtained due to uterine position
  3. Participants whose treatments were canceled for any reason before embryo transfer
  4. Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
  5. Participants who had 2 embryo transfer
  6. Presence of low quality (<2BB) blastocyst
  7. > 15% loss of viability in the embryo during embryo thawing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with endometrial compaction
Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement
Drug: Progesterone
ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
Other Names:
  • Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal
without endometrial compaction
Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement
Drug: Progesterone
ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
Other Names:
  • Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
ongoing pregnancy rates.
Time Frame: 1 year
pregnancy beyond 12 weeks of gestational age.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
Time Frame: On the day of frozen embryo transfer
comparison of progesterone levels and endometrial thickness
On the day of frozen embryo transfer
Clinical pregnancy rate
Time Frame: 6-7 weeks after the last menstrual period of the patient
6th week gestational age
6-7 weeks after the last menstrual period of the patient
Implantation rate
Time Frame: 5 weeks after the last menstrual period of the patient
Percentage of gestational sacs compared to the number of embryos transferred
5 weeks after the last menstrual period of the patient
Clinical miscarriage
Time Frame: after 5th gestational week
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
after 5th gestational week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

April 15, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

January 17, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Estimate)

January 2, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AkdenizUKD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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