跳至主要内容
临床试验/NCT05613049
NCT05613049招募中不适用

Confounding Factors of Chronic Endometritis in Women With Reproductive Failure

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2023年1月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
720
试验地点
1
主要终点
Live birth rate

研究概览

简要总结

The aim of the study is to investigate the confounding factors of chronic endometritis and therapeutic benefits of antibodies targeting plasma cells in women with reproductive failure.

详细描述

Eligible women, based on the inclusion and exclusion criteria, will be recruited from the IVF and/ or miscarriage clinic in the Prince of Wales Hospital/ CUHK medical centre (CUMC). Endometrial sampling (ES) will alternatively be conducted during mid-luteal phase. In natural cycles, all the subjects will have a daily urine test from day 9 of the menstrual cycle to identify the Luteinizing Hormone (LH) surge. The ES will be obtained precisely 7 days after LH surge. In artificial cycles, 6mg estradiol will be given daily orally from day 2 of the menstrual cycle for 14+/-1-2 days. Transvaginal ultrasound will be performed on day 14 of the estrogen therapy to assess the endometrial thickness and to exclude ovarian activity. If endometrial thickness is ≥8 mm, plasma progesterone level is < 4nmol/L, progesterone will be commenced using either Endometrin (Ferring, Saint-Prex, Switzerland) 100 mg TDS vaginally. ES will be obtained using a Pipelle sampler as an outpatient procedure. The ES will be obtained precisely 5 days after progesterone supplementation.

Immunohistochemical staining will be used to determine plasma cells by using a mouse antihuman monoclonal primary anti-CD138 antibody and anti-CD38 antibody. The total number of plasma cell present in the stroma of the entire specimen will be determined and expressed as plasma cell count per unit area of the specimen. If CE is present, antibiotics will be given following the guideline from the Hospital Authority (HA). Then ES will be taken again to be re-examined by histology and microbiology.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Live birth rate

时间窗: 31 December 2027

compare the brith rate between the group and cohort

次要结局

  • Compare the implantation rate between groups(31 March 2028)
  • Compare the pregnancy rate between groups(31 March 2028)
  • Compare the miscarriage rate between groups(31 March 2028)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chung Pui Wah Jacqueline

Associate Professor

Chinese University of Hong Kong

研究点 (1)

Loading locations...

相似试验