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

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

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.

Study Overview

• Status: Unknown
• Conditions: Infertility, Female; Infertility of Uterine Origin; Implantation; Placenta
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34758
    • Recruiting
    • Ataşehir Memorial Hospital IVF Department
    • Contact: Fırat Tulek, MD; Phone Number: +905306084874; Email: firattulek@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women underwent frozen embryo transfer

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cem Demirel

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2020
• Primary Completion (ANTICIPATED): January 15, 2021
• Study Completion (ANTICIPATED): February 15, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 13, 2020
• First Posted (ACTUAL): September 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: progesterone; frozen-thawed embryo transfer; endometrial compaction
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone
• Other Study ID Numbers: 9995381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No