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

Inti Labs

Status and phase: Completed; Early Phase 1

Conditions: Fertility

Treatments: Genetic: Small RNA sequencing

Study type: Interventional

Funder types: Industry

Identifiers

NCT06786273

CS2-22033

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: Female

Ages: 25 to 38 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

62 participants in 5 patient groups

P+3

Other group

Description:

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

Treatment:

Genetic: Small RNA sequencing

P+4

Other group

Description:

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

Treatment:

Genetic: Small RNA sequencing

P+5

Other group

Description:

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

Treatment:

Genetic: Small RNA sequencing

P+6

Other group

Description:

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

Treatment:

Genetic: Small RNA sequencing

P+7

Other group

Description:

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

Treatment:

Genetic: Small RNA sequencing