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

Sponsor

Cem Demirel (Other)

Overall Status

Recruiting

CT.gov ID

NCT04554654

Collaborator

(none)

200

Enrollment

Location

Anticipated Duration (Months)

24.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female Infertility of Uterine Origin Implantation; Placenta	Diagnostic Test: transvaginal ultrasound,

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 15, 2020

Anticipated Primary Completion Date :

Jan 15, 2021

Anticipated Study Completion Date :

Feb 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
frozen embryo transfer cycles patients undergoing frozen embryo transfer with artificial hormone replacement	Diagnostic Test: transvaginal ultrasound, 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 Other Names: serum progesterone level measurement

Arm

Intervention/Treatment

frozen embryo transfer cycles

patients undergoing frozen embryo transfer with artificial hormone replacement

Diagnostic Test: transvaginal ultrasound,

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

Other Names:

serum progesterone level measurement

Outcome Measures

Primary Outcome Measures

Ongoing pregnancy rates [12 weeks after the last menstrual period of the patient]
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

Secondary Outcome Measures

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]
endometrium compacted (became thinner) after the administration of progesterone
Clinical pregnancy rate [6-7 weeks after the last menstrual period of the patient]
Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation
Implantation rate [5 weeks after the last menstrual period of the patient]
Percentage of gestational sacs compared to the number of embryos transferred
Clinical miscarriage rate [after 5th gestational week]
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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