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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trio Fertility | Recruiting | Toronto | Ontario | M5G 2K4 | Canada |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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We will measure the percentage of senescent cells in endometrial biopsies by Sudan Black-B (SBB) immunohistochemistry, since this is a specific marker of cell senescence and can be performed on formalin fixed, paraffin-embedded tissue. This assay also allows us to test archived samples for women in the control group who have already had an endometrial biopsy. We will also freeze part of the endometrial biopsy sample for RNA extraction for senescent biomarker expression (BMI-1, p16lnka4, p14ARF, Cyclin-D1, and CDK4 by RT-PCR) and protein determination (western blotting) for confirmation of the SBB staining results
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| D000091662 | Genital Diseases |