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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04733235
• Other study ID #: AkdenizUKD
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 15, 2021

Study information

• Verified date: December 2022
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: July 15, 2021
• Est. primary completion date: April 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Female Infertility
• Frozen-thawed Embryo Transfer
• Infertility
• Infertility, Female

Intervention

Drug:
• Progesterone
ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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):503-5 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in endometrial thickness	changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.	1 year
Primary	ongoing pregnancy rates.	pregnancy beyond 12 weeks of gestational age.	1 year
Secondary	The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer	comparison of progesterone levels and endometrial thickness	On the day of frozen embryo transfer
Secondary	Clinical pregnancy rate	6th week gestational age	6-7 weeks after the last menstrual period of the patient
Secondary	Implantation rate	Percentage of gestational sacs compared to the number of embryos transferred	5 weeks after the last menstrual period of the patient
Secondary	Clinical miscarriage	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac	after 5th gestational week