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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Ontario
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Toronto, Ontario, Canadá, M5G 2K4
- Recrutamento
- Trio Fertility
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Contato:
- Yasaman Sadeghi, M.Sc.
- Número de telefone: 2268 416-506-0804
- E-mail: yasamans@triofertility.com
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Contato:
- Robert. F. Casper, Dr.
- Número de telefone: 3228 416-506-0804
- E-mail: casper@lunenfeld.ca
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Investigador principal:
- Robert. F. Casper, Dr.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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). |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Senescent cells presence
Prazo: 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.
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 3533
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