Time Course of Endometrium's Gene Expression Profiles Using Endometrial Tissue and Blood Samples

January 15, 2025 updated by: Inti Labs

Time Course of Endometrium's Gene Expression and DNA Methylation Profiles Using Endometrial Tissue and Blood Samples

This study aims to investigate whether the expression levels of microRNA (miRNA) in endometrial tissue and blood samples at various time points after ovulation can serve as biomarkers for assessing endometrial receptivity.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Early Phase 1

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
      • Taichung, Taiwan
        • Lee Women's 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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Regular menstrual cycle of 28-32 days.
  • Between 25-38 years old.
  • BMI between 18 to 30.
  • Endogenous progesterone (P4) level of < 1 ng/mL prior to exogenous progesterone administration

Exclusion Criteria:

  • Suspected intrauterine abnormality.
  • Women who are breastfeeding
  • Have a history of pelvic inflammatory disease, reproductive tract-related diseases, sexually transmitted diseases, systemic diseases or endocrine diseases.
  • History of major illness.
  • Use of hormonal contraceptives or intrauterine devices in the past 3 months.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: P+3
Women who get their blood drawn and endometrial tissue biopsy taken at 3 days after progesterone administration starts.
Genetic: Small RNA sequencing
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.
Other: P+4
Women who get their blood drawn and endometrial tissue biopsy taken at 4 days after progesterone administration starts.
Genetic: Small RNA sequencing
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.
Other: P+5
Women who get their blood drawn and endometrial tissue biopsy taken at 5 days after progesterone administration starts.
Genetic: Small RNA sequencing
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.
Other: P+6
Women who get their blood drawn and endometrial tissue biopsy taken at 6 days after progesterone administration starts.
Genetic: Small RNA sequencing
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.
Other: P+7
Women who get their blood drawn and endometrial tissue biopsy taken at 7 days after progesterone administration starts.
Genetic: Small RNA sequencing
The blood and endometrial tissue samples collected from the study groups will undergo small RNA sequencing to investigate the microRNA expression profiles associated with that phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miRNA expression profiles
Time Frame: 1 month
The samples collected would undergo small RNA sequencing in order to investigate the miRNA expression profiles of the patients and differences in expression profiles between the different intervention groups.
1 month

Collaborators and Investigators

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

Sponsor

Inti Labs

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)

March 31, 2023

Primary Completion (Actual)

February 6, 2024

Study Completion (Actual)

February 6, 2024

Study Registration Dates

First Submitted

January 15, 2025

First Submitted That Met QC Criteria

January 15, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 15, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CS2-22033

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

product manufactured in and exported from the U.S.

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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