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

NCT ID: NCT04554654

Last Updated: 2021-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-15
• Study Completion Date: 2021-02-15

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

frozen embryo transfer cycles

patients undergoing frozen embryo transfer with artificial hormone replacement

transvaginal ultrasound,

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

serum progesterone level measurement

Eligibility Criteria

Inclusion Criteria

1. Woman aged 20-40 years

2. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles

3. Having available blastocyst(s) cryopreserved by vitrification method.

Exclusion Criteria

1. Recurrent implantation failure

2. Recurrent pregnancy loss

3. Presence of uterine pathology

4. Requirement for fresh embryo(s);

5. Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy

6. Allergy history for relevant drugs

7. Body mass index of <18 or >38 kg/m2 at screening

8. Current breastfeeding or pregnancy

9. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests

10. Natural or modified natural cycles

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cem Demirel

OTHER

Sponsor Role: lead

Responsible Party

Cem Demirel

professor doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ataşehir Memorial Hospital IVF Department

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Cem Demirel, MD

Role: CONTACT

cemdemirel@hotmail.com

+905333229039

Facility Contacts

Fırat Tulek, MD

Role: primary

firattulek@yahoo.com

+905306084874

Other Identifiers

9995381

Identifier Type: -

Identifier Source: org_study_id