Senescent Endometrial Cells in Patients with Thin Endometrial Lining

Recruiting

• Conditions: Cell Senescence; Asherman's Syndrome; Thin Endometrial Lining
• Interventions: Procedure: Endometrial Biopsy

• Registration Number: NCT06450301
• Lead Sponsor: Trio Fertility

Brief Summary

The goal of this observational study is to determine if thin endometrial lining that is unresponsive to estrogen might be associated with the presence of senescent cells in patients following long-term use of oral contraceptives. The main question it aims to answer is:

Are there any senescent cells present in thin endometrial lining?

During the luteal phase of the cycle, participants will will undergo:

* Gynecologic US to measure the endometrial lining thickness and pattern.

* Endometrial biopsy with Pipelle catheter

Detailed Description

The investigators hypothesized that senescent cells in the endometrium may be the cause of the failure of thin endometrium to respond to normal growth stimuli such as estrogen.

The outcome that research team anticipate to measure is the percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-03
• Study First Posted: 2024-06-10
• Study Start: 2024-09-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-21
• Primary Completion: 2027-01
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Age 18-39
• BMI - up to 35
• Thin endometrium after OCP use
• Asherman's syndrome
• Women already undergoing endometrial biopsy for infertility testing (eg. EMMA testing)
• Women with archived endometrial biopsy samples

Exclusion Criteria

• Women with systemic disease (Rheumatic disease, DM)
• Women with coagulopathies
• Women with active pelvic inflammatory process
• Uterine anomalies
• Pregnant women
• Any hormonal contraception use or IUD

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thin endometrial lining	Endometrial Biopsy	Patients following long-term use of oral contraceptives with known thin endometrial lining (less than 7mm, confirmed in at least two cycles and unresponsive to estrogen-induced growth). We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase.
Control	Endometrial Biopsy	Patients already scheduled to undergo an endometrial biopsy for infertility management. We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase. In some cases, we may be able to access archived endometrial samples from women in the control group who agree to participate and who have already had an endometrial biopsy.
Asherman's syndrome	Endometrial Biopsy	Patients with Asherman's syndrome following Dilation and curettage (D\&C). We will ask each woman to undergo an endometrial biopsy as part of the study during their luteal phase.

Primary Outcome Measures

Name	Time	Method
Senescent cells presence	Through study completion, an average of 3 years.	Percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.

Trial Locations

Locations (1)

Trio Fertility; 🇨🇦 Toronto, Ontario, Canada