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

NCT06786273 | Completed Early Phase 1

• 1 other identifier: CS2-22033
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fertility

Keywords

miRNAs; microRNAs; time course; blood

Outcome Measures

Primary Outcomes (1)

• miRNA expression profiles

  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

Study Arms (5)

P+3

OTHER

Women who get their blood drawn and endometrial tissue biopsy taken at 3 days after progesterone administration starts.

Genetic: Small RNA sequencing

P+4

OTHER

Women who get their blood drawn and endometrial tissue biopsy taken at 4 days after progesterone administration starts.

Genetic: Small RNA sequencing

P+5

OTHER

Women who get their blood drawn and endometrial tissue biopsy taken at 5 days after progesterone administration starts.

Genetic: Small RNA sequencing

P+6

OTHER

Women who get their blood drawn and endometrial tissue biopsy taken at 6 days after progesterone administration starts.

Genetic: Small RNA sequencing

P+7

OTHER

Women who get their blood drawn and endometrial tissue biopsy taken at 7 days after progesterone administration starts.

Genetic: Small RNA sequencing

Interventions

Small RNA sequencing GENETIC

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.

P+3; P+4; P+5; P+6; P+7

Eligibility Criteria

• Age: 25 Years - 38 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inti Labs: lead

Study Sites (1)

Lee Women's Hospital

Taichung, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 22, 2025
• Study Start: March 31, 2023
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)