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

Study Overview
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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

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

Conditions
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Infertility, Female Infertility, Frozen-thawed Embryo Transfer

Intervention / Treatment
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* Drug: Progesterone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with endometrial compaction<br>Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement | Drug: Progesterone<br>* ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.<br>* Other names: Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal;|
| without endometrial compaction<br>Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement | Drug: Progesterone<br>* ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.<br>* Other names: Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ongoing pregnancy rates. | pregnancy beyond 12 weeks of gestational age. | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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female, infertility, female infertility, frozen- thawed embryo transfer