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

Completed

• Conditions: Female Infertility; Frozen-thawed Embryo Transfer; Infertility
• Interventions: Drug: Progesterone

• Registration Number: NCT04733235
• Lead Sponsor: Akdeniz University

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

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-01-17
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-02-02
• Primary Completion: 2021-04-15
• Study Completion: 2021-07-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-29
• Last Update Posted: 2023-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with endometrial compaction	Progesterone	Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement
without endometrial compaction	Progesterone	Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rates.	1 year	pregnancy beyond 12 weeks of gestational age.
The change in endometrial thickness	1 year	changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	6-7 weeks after the last menstrual period of the patient	6th week gestational age
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
Clinical miscarriage	after 5th gestational week	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
Implantation rate	5 weeks after the last menstrual period of the patient	Percentage of gestational sacs compared to the number of embryos transferred

Trial Locations

Locations (1)

Akdeniz University; 🇹🇷 Antalya, Turkey