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

NCT04554654 | Unknown

• 1 other identifier: 9995381
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

frozen-thawed embryo transfer; endometrial compaction; progesterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Clinical pregnancy rate

  6-7 weeks after the last menstrual period of the patient

• Implantation rate

  5 weeks after the last menstrual period of the patient

• Clinical miscarriage rate

  after 5th gestational week

Study Arms (1)

frozen embryo transfer cycles

patients undergoing frozen embryo transfer with artificial hormone replacement

Diagnostic Test: transvaginal ultrasound,

Interventions

transvaginal ultrasound, 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

Also known as: serum progesterone level measurement

frozen embryo transfer cycles

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Female patients underwent infertility treatment
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women underwent frozen embryo transfer

You may qualify if:

• Woman aged 20-40 years
• Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
• Having available blastocyst(s) cryopreserved by vitrification method.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cem Demirel: lead

Study Sites (1)

Ataşehir Memorial Hospital IVF Department

Istanbul, 34758, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Cem Demirel, MD

CONTACT

+905333229039; cemdemirel@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor doctor

Study Record Dates

• First Submitted: September 4, 2020
• First Posted: September 18, 2020
• Study Start: June 15, 2020
• Primary Completion: January 15, 2021
• Study Completion: February 15, 2021
• Last Updated: January 11, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)