Senescent Endometrial Cells in Patients with Thin Endometrial Lining
NCT ID: NCT06450301
Last Updated: 2024-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-09-11
2027-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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).
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.
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).
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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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 coagulopathies
* Women with active pelvic inflammatory process
* Uterine anomalies
* Pregnant women
* Any hormonal contraception use or IUD
18 Years
39 Years
FEMALE
Yes
Sponsors
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Trio Fertility
OTHER
Responsible Party
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Dr. Robert F. Casper
Scientific Director, MD, FRCSC, REI
Locations
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Trio Fertility
Toronto, Ontario, Canada
Countries
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Facility Contacts
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Robert. F. Casper, Dr.
Role: backup
Other Identifiers
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3533
Identifier Type: -
Identifier Source: org_study_id
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