Senescent Endometrial Cells in Patients With Thin Endometrial Lining

Asherman's Syndrome Clinical Trial

Official title:

Is Thin Endometrial Lining Associated With Senescent Endometrial Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06450301
• Other study ID #: 3533
• Status: Recruiting
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: June 2024
• Source: Trio Fertility
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Asherman's Syndrome

Intervention

Procedure:
• Endometrial Biopsy
An endometrial biopsy is the removal of a small piece of tissue from the endometrium, which is the lining of the uterus. Endometrial biopsies are commonly done to check for the window of implantation, to determine ovulation or for enhancing implantation (procedure called endometrial scratching). For this purpose, we will use a "Pipelle" catheter. This procedure is very common in gynecologic practice and generally considered safe. In most of the cases this procedure is indicated for evaluation of irregular vaginal bleeding, vaginal bleeding in post-menopausal women and for infertility related problems (recurrent implantation failures for example).

Locations

Country	Name	City	State
Canada	Trio Fertility	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Trio Fertility

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Senescent cells presence	Percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.	Through study completion, an average of 3 years.