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)
• Enrollment: 250
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 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
Infertility; Female Infertility; Frozen-thawed Embryo Transfer	Drug: Progesterone

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: ŞAFAK 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 ŞAFAK OLGAN, ASSOCIATE PROFESSOR, Akdeniz University: infertility; female infertility; frozen- thawed embryo transfer; female
• Additional relevant MeSH terms: Infertility; Infertility, Female; Progesterone

Study Results

No Results Posted as of Feb 2, 2021