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

• Conditions: Infertility, Female; Infertility of Uterine Origin; Implantation; Placenta
• Interventions: Diagnostic Test: transvaginal ultrasound,

• Registration Number: NCT04554654
• Lead Sponsor: Cem Demirel

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.

Study Timeline

• Study Start: 2020-06-15
• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-13
• Study First Posted: 2020-09-18
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11
• Primary Completion: 2021-01-15
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
frozen embryo transfer cycles	transvaginal ultrasound,	patients undergoing frozen embryo transfer with artificial hormone replacement

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical miscarriage rate	after 5th gestational week	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
Implantation rate	5 weeks after the last menstrual period of the patient	Percentage of gestational sacs compared to the number of embryos transferred
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

Trial Locations

Locations (1)

Ataşehir Memorial Hospital IVF Department; 🇹🇷 İstanbul, Turkey