Senescent Endometrial Cells in Patients With Thin Endometrial Lining
Is Thin Endometrial Lining Associated With Senescent Endometrial Cells
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
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní místa
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Ontario
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Toronto, Ontario, Kanada, M5G 2K4
- Nábor
- Trio Fertility
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Kontakt:
- Yasaman Sadeghi, M.Sc.
- Telefonní číslo: 2268 416-506-0804
- E-mail: yasamans@triofertility.com
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Kontakt:
- Robert. F. Casper, Dr.
- Telefonní číslo: 3228 416-506-0804
- E-mail: casper@lunenfeld.ca
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Vrchní vyšetřovatel:
- Robert. F. Casper, Dr.
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
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. |
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. |
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. |
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). |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Senescent cells presence
Časové okno: 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. |
Through study completion, an average of 3 years.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 3533
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