此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Senescent Endometrial Cells in Patients With Thin Endometrial Lining

2026年10月29日 更新者:Dr. Robert F. Casper、Trio Fertility

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

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G 2K4
        • 招聘中
        • Trio Fertility
        • 接触:
        • 接触:
        • 首席研究员:
          • Robert. F. Casper, Dr.

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 39年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
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).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Senescent cells presence
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年9月11日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2024年5月28日

首先提交符合 QC 标准的

2024年6月3日

首次发布 (实际的)

2024年6月10日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅