Recruiting

Observational Study

Sponsor:

Trio Fertility

Code:

NCT06450301

Conditions

Asherman's Syndrome

Thin Endometrial Lining

Cell Senescence

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

Endometrial Biopsy

Study Details

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

Conditions

Asherman's Syndrome

Thin Endometrial Lining

Cell Senescence

Study ID

NCT06450301

Start date

Sep 11, 2024

Status verified date

Nov, 2024

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 39

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Thin endometrial lining

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.

Asherman's syndrome

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.

Control

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.

Interventions

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).

Primary outcome measure

  • Senescent cells presence [ Time Frame: Through study completion, an average of 3 years. ]

Central Contacts and Locations

Locations

Trio Fertility

Recruiting

Toronto, Ontario, Canada, M5G 2K4

Contacts

More Information

Sponsor

Trio Fertility

Last update posted

Nov 21, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Trio Fertility on 2024-11-21.