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

Sponsor
Akdeniz University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04733235
Collaborator
(none)
250
1
24
10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. The change in millimeters endometrial thickness and ongoing pregnancy rates. [18 months]

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

    Secondary Outcome Measures

    1. 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]

      comparison of progesterone levels and endometrial thickness

    2. Clinical pregnancy rate [6-7 weeks after the last menstrual period of the patient]

      6th week gestational age

    3. Implantation rate [5 weeks after the last menstrual period of the patient]

      Percentage of gestational sacs compared to the number of embryos transferred

    4. Clinical miscarriage [after 5th gestational week]

      pregnancy loss after ultrasonographic detection of an intrauterine gestational sac

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Akdeniz University Antalya Turkey

    Sponsors and Collaborators

    • Akdeniz University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ┼×AFAK OLGAN, ASSOCIATE PROFESSOR, Akdeniz University
    ClinicalTrials.gov Identifier:
    NCT04733235
    Other Study ID Numbers:
    • AkdenizUKD
    First Posted:
    Feb 2, 2021
    Last Update Posted:
    Feb 2, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ┼×AFAK OLGAN, ASSOCIATE PROFESSOR, Akdeniz University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 2, 2021