Skip to main content
OpenTrials
Completed

NCT Number: NCT04733235

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Akdeniz University

Antalya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone

Drug

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

Primary outcomes

  1. 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.

  2. ongoing pregnancy rates.

    Time frame: 1 year

    pregnancy beyond 12 weeks of gestational age.

Secondary outcomes

  1. 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

  2. Clinical pregnancy rate

    Time frame: 6-7 weeks after the last menstrual period of the patient

    6th week gestational age

  3. 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

  4. Clinical miscarriage

    Time frame: after 5th gestational week

    pregnancy loss after ultrasonographic detection of an intrauterine gestational sac

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 2, 2021
Registry last updated
Jan 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.