Expression of Endometrium During Window of Implantation

August 1, 2024 updated by: Li-Te Lin, Kaohsiung Veterans General Hospital.

To Investigate the Expression of Endometrium During Window of Implantation Between Natural Cycles and Artificial Cycles

The aim of this study was to investigate the expression of endometrium during window of implantation between natural cycles and artificial cycles.

Study Overview

Status

Terminated

Conditions

Detailed Description

Due to progress of embryo vitrification in recent years, frozen embryo transfer (FET) of in vitro fertilization (IVF) has already been a world trend. The most used two protocols of FET are natural cycles (NCs) and artificial cycles (ACs). Recent studies showed that IVF outcomes of NCs were superior to ACs. We hypothesized that the result may be because of better endometrial receptivity of NCs compared to ACs. In NCs, no hormonal agents were administrated. Thus, endometrial receptivity was not disturbed by hormone and became better. However, there were few studies to explore the issue. Therefore, the aim of this study was to investigate the expression of endometrium during window of implantation (WOI) between NCs and ACs.

The study will be performed from July 1st, 2022 to December 31th, 2023 in our reproductive center. We plan to enroll 60 infertile women who have underwent IVF cycles and would like to receive endometrial receptivity assay. We divide the participants into two groups, NCs and ACs. In NCs, no hormonal agents will be used. We identify ovulation day via serial hormone data and sample endometrium during WOI (LH surge + 7 days). In ACs, first, estrogen will be given for 10~14 days and then transvaginal sonography will be conducted. When endometrial thickness reaches 8 mm at least, progesterone will be prescribed. Endometrium is sampled during WOI (P4 + 5 days). We will record basic characteristics, infertility history, hormone data, ovarian reserve and endometrial thickness of infertile women in both groups. Endometrial samples will be assessed miRNA, implantation factors, uterine NK cells and T cells in both groups.

Study Type

Observational

Enrollment (Actual)

3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Infertile women aged 30-44 years with implantation failure at least two times

Description

Inclusion Criteria:

  • Age: 30-44 years
  • BMI: 18~30 kg/m2
  • Implantation failure at least two times

Exclusion Criteria:

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Malignancy
  • Donor cycle

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Natural cycles
Endometrium will be sampled at the day of LH surge + 7 days.
Artificial cycles
Endometrium will be sampled at the day of P4 + 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of endometrium
Time Frame: through study completion, an average of 1.5 year
miRNA
through study completion, an average of 1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation factors of endometrium
Time Frame: through study completion, an average of 1.5 year
HOXA10
through study completion, an average of 1.5 year
Immune cells of endometrium
Time Frame: through study completion, an average of 1.5 year
Uterine NK cells
through study completion, an average of 1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Director: Li-Te Lin, Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 26, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KSVGH22-CT7-07

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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