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NCT Number: NCT06450301

Senescent Endometrial Cells in Patients with Thin Endometrial Lining

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

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Key information

Conditions

Asherman's Syndrome Cell Senescence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Thin Endometrial Lining Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endometrial biopsy

Procedure

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 outcomes

  1. Senescent cells presence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Trio Fertility

Other

Registry information

Official study title

Is Thin Endometrial Lining Associated with Senescent Endometrial Cells

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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