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

NCT ID: NCT06786273

Last Updated: 2025-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2024-02-06

Brief Summary

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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.

Detailed Description

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Conditions

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Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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P+3

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

Group Type OTHER

Small RNA sequencing

Intervention Type 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+4

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

Group Type OTHER

Small RNA sequencing

Intervention Type 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+5

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

Group Type OTHER

Small RNA sequencing

Intervention Type 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+6

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

Group Type OTHER

Small RNA sequencing

Intervention Type 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+7

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

Group Type OTHER

Small RNA sequencing

Intervention Type 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.

Interventions

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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.

Intervention Type GENETIC

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inti Labs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lee Women's Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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CS2-22033

Identifier Type: -

Identifier Source: org_study_id

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