Progesterone Levels and Endometrial Compaction in Frozen-Thawed Embryo Transfer Cycles

Study Overview
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Brief Summary
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This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment.

Detailed Description
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This study is planned to be conducted by prospectively evaluating approximately 200 frozen embryo transfers within 6 months in a single center. Patients planned to be included in the study are started estrodiol 6 mg / day on day2-3 of mensturation. 12 days after the start of estrogen, patients who have endometrial thickness over 7 mm are then started vaginal progesterone supplementation as per routine practice and are eventually proceeded to embryo transfer either on day 4 or 6 of progesterone supplementation. In this study investigators are intended to measure endometrial thickness transvaginally on the day of embryo transfer to accurately determine the presence of endometrial compaction, assess serum progesterone levels, evaluate any possible correlations between endometrial compaction, serum progesterone levels and pregnancy rates.

Official Title
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The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer

Conditions
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Infertility, Female, Infertility of Uterine Origin, Implantation; Placenta

Intervention / Treatment
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* Diagnostic Test: transvaginal ultrasound,


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman aged 20-40 years Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles Having available blastocyst(s) cryopreserved by vitrification method. Exclusion Criteria: Recurrent implantation failure Recurrent pregnancy loss Presence of uterine pathology Requirement for fresh embryo(s); Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy Allergy history for relevant drugs Body mass index of <18 or >38 kg/m2 at screening Current breastfeeding or pregnancy Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests Natural or modified natural cycles

Ages Eligible for Study
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Minimum Age: 20 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 |
| --- | --- |
| frozen embryo transfer cycles<br>patients undergoing frozen embryo transfer with artificial hormone replacement | Diagnostic Test: transvaginal ultrasound,<br>* transvaginal ultrasound performed on day of the start of progesterone supplementation and on the day of frozen embryo transfer; serum progesterone level measurement on day of frozen embryo transfer<br>* Other names: serum progesterone level measurement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rates | Presence of at least one live fetus at the end of the 12th gestational week in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer | 12 weeks after the last menstrual period of the patient | 

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 | endometrium compacted (became thinner) after the administration of progesterone | On the day of frozen embryo transfer | 
| Clinical pregnancy rate | Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation | 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 rate | 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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frozen-thawed embryo transfer, endometrial compaction, progesterone