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

NCT ID: NCT04733235

Last Updated: 2023-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-07-15

Brief Summary

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

Detailed Description

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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

Conditions

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Infertility Female Infertility Frozen-thawed Embryo Transfer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with endometrial compaction

Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Progesterone

Intervention Type DRUG

ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

without endometrial compaction

Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement

Progesterone

Intervention Type DRUG

ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Interventions

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Progesterone

ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Intervention Type DRUG

Other Intervention Names

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Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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ŞAFAK OLGAN

ASSOCIATE PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.

Reference Type RESULT
PMID: 31248618 (View on PubMed)

Other Identifiers

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AkdenizUKD

Identifier Type: -

Identifier Source: org_study_id

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