Senescent Endometrial Cells in Patients with Thin Endometrial Lining
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-39
SponsorTrio Fertility
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-39
BMI - up to 35
Thin endometrium after OCP use
Asherman's syndrome
Disqualifiers
Women with systemic disease (Rheumatic disease, DM)
Women with coagulopathies
Women with active pelvic inflammatory process
Uterine anomalies
Trial population
We intend to recruit 30 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 also recruit 20 women with Asherman's syndrome following D\&C. We will ask each woman to undergo an endometrial biopsy as part of the study. As a control group, we will recruit 50 patients already scheduled to undergo an endometrial biopsy for infertility management (EMMA testing, endometrial scratching for IVF cycles). Endometrial biopsies are standard procedures during infertility investigations. 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Endometrial Biopsy
Procedure/SurgeryAn 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).
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Thin endometrial lining1 intervention
Group B: Asherman's syndrome1 intervention
Group C: Control1 intervention
Trial outcomes
Primary outcomes
1
Senescent cells presence
Percentage of senescent cells in the endometrial biopsies of women with thin endometrium compared to the control group biopsies.
Time frame
Through study completion, an average of 3 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Trio Fertility
Lead sponsor
University of Toronto
Sponsor institution
Source ClinicalTrials.gov