Endometrial Compaction in Assissted Reproduction

May 12, 2022 updated by: Ayman Ahmad Abdelraof Ahmad Askar, Assiut University

The Impact of Endometrial Compaction on Ongoing Pregnancy Rate in Assisted Reproductive Technology Cycles : Prospective Cohort Study

To record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Clinical pregnancy rate in IVF cycles depends on embryo quality and endometrial receptivity . It is challenging to assess endometrial receptivity. Measuring endometrial thickness by ultrasonography is a simple , noninvasive and accurate method to do so. Many studies have implicated endometrial thickness and pattern as prognostic parameters for successful outcomes in IVF-ET.

Some studies have suggested a minimal thickness for a successful pregnancy to occur, while others have reported adverse effects of increased endometrial thickness above which pregnancy is unlikely to occur.

Now there is a novel hypothesis that not only the initial endometrial thickness can affect implantation rate and clinical pregnancy rate ,but also the decrease in endometrial thickness in the time interval between the ovulation triggering and the embryo transfer or what is called endometrial compaction increases the implantation and clinical pregnancy rate

Study Type

Observational

Enrollment (Anticipated)

145

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Recruiting
        • Women Health Hospital
        • Contact:

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

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women undergoing IVF/ICSI.

Description

Inclusion Criteria:

  • • Infertile women aged 18 years to 40 years undergoing IVF/ ICSI for any indication.

Exclusion Criteria:

  • • History of recurrent pregnancy loss (≥ 2 spontaneous abortions) and/or history of recurrent (≥ 2) ICSI failure after embryo transfer.

    • Uterine malformations.
    • Uncorrected hydrosalpinx.
    • Intrauterine conditions affecting pregnancy outcomes such as ( intrauterine adhesions, fibroids, polyps).
    • Any previous hysteroscopic surgery eg. Metroplasty or hysteroscopic myomectomy or uterine surgeries involving the endometrium eg. myomectomy during which uterine cavity was opened.
    • History suggesting endometritis.
    • Use of hCG for endometrial preparation or luteal phase support.
    • Poor quality embryos( according to Istanbul consensus workshop on embryo assessment )

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
with compaction
those whose endometrial thickness is calculated to decrease by the time of embryo transfer compared with the thickness at the day of ovulation trigger, analyzed according to the degree of compaction, i.e., 5%, 10%, 15%, or 20% decrease thickness
Diagnostic test: transvaginal ultrasound on the uterus

Transvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle:

In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer
without compaction
those who had an increase in their endometrial thickness or whose thickness decreased less than 5%
Diagnostic test: transvaginal ultrasound on the uterus

Transvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle:

In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 12 weeks after embryo transfer if hCG tested positive
rate of ongoing pregnancy in patients who have endometrial compaction
12 weeks after embryo transfer if hCG tested positive

Collaborators and Investigators

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

Sponsor

Assiut University

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)

August 20, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

July 10, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 12, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC

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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