Implantation Test for Endometrial Receptivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Proteome profile
研究概览
简要总结
Background Miscarriage is the most frequent complication of pregnancy and represents the spontaneous loss of the embryo or foetus before it is able to survive independently (24 weeks of gestation). It affects up to 50% of pregnancies with the vast majority (80%) occurring at pre-clinical stage before the woman recognises the pregnancy. Up to 5% of couples suffer recurrent miscarriage defined as 2-3 or more miscarriages leading to physical, emotional and financial consequences for couples, doctors and medical systems.
Different maternal health problems (thyroid disease, sticky blood, autoimmune disease, anatomical anomalies of the womb) and embryo defects may be responsible for some of the miscarriages; however, more than 50% of the occurrences have no identifiable cause based on the current diagnostic tests.
Aim The aim of the present research proposal is to understand the role of the lining of the womb in miscarriage and to explore the development of a potential implantation test that is cost-effective and may be implemented in clinical practice.
Methods Over a period of two years, women who suffered recurrent miscarriage will be approached in the advanced miscarriage clinic at Birmingham Women's Hospital during their routine appointment. Participants will be invited to participate by undergoing chromohysteroscopy and/or a biopsy from the lining of the womb during an outpatient appointment.
Chromohysteroscopy is based on a routine hysteroscopy which involves visualising the inside of the womb using a narrow telescope passed through the neck of the womb (cervix). "Chromo" comes from the fact that an iodine based dye will be injected to increase the power of the test.
The biopsy will be taken using a narrow plastic tube passed through the cervix. It is a standard diagnostic test for women with abnormal bleeding. As part of the present research, different cells and molecules will be analysed from the biopsy sample.
详细描述
The Tommy's National Centre for Miscarriage Research in Birmingham is a Research Centre which brings together an interdisciplinary translational medicine research grouping jointly at the Birmingham Women's and Children's NHS Foundation Trust (BWCNFT) and the University of Birmingham (UoB). The overarching Tommy's Centre funding includes sites at the University of Warwick and Imperial College London. The Centre is dedicated to research across all aspects of miscarriage and early pregnancy complications including basic scientific, medical, social and ethical issues.
This research project will occur alongside an advanced miscarriage clinic at Birmingham Women's Hospital. The Study Office belongs to the University of Birmingham and is located within the Birmingham Women's Hospital (Academic Department, 3rd floor). Computers are linked to the University's Network and all the electronic data will be held within this network.
The research project is divided into a number of three work packages and the findings from these will build on each other. Therefore, we have incorporated each of these distinct work packages within this research project protocol, with methodological details and objectives of each.
Work package 1: Target Product Profile (TPP) The TPP will convey information regarding the proposed use, context of use, patients' and clinicians' needs for an endometrial test in relation to endometrial receptivity, recurrent miscarriage and recurrent implantation failure.
Women who suffer recurrent miscarriage are referred for routine care to the Recurrent Miscarriage Clinic within Birmingham Women's Hospital by their GP or by other NHS Early Pregnancy Units. Women attending the Recurrent Miscarriage Clinic will be invited to fill in a questionnaire during their waiting time prior to the consultation by one of the research nurses who work within the Recurrent Miscarriage Clinic. The purpose of the questionnaire is to gain insight into women's view and expectations in relation to a new endometrial receptivity test.
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
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women diagnosed with unexplained recurrent miscarriage (2+ miscarriages with negative standard miscarriage investigations)
- •regular menstrual cycles
排除标准
- •women who have irregular menstrual cycles or those who require fertility treatments
- •any positive finding or health issue that may explain the diagnosis of recurrent miscarriage
- •women who are pregnant at the time of the study investigations
- •women who are participants in other interventional studies or trials
结局指标
主要结局
Proteome profile
时间窗: 2 years
Proteomics analysis of endometrial samples.
Iodine absorption
时间窗: 2 years
Iodine interaction with the mid luteal phase endometrium.
Transcriptome profile
时间窗: 2 years
Transcriptomics analysis of endometrial samples.
Metabolome profile
时间窗: 2 years
Metabolomics analysis of endometrial samples.
次要结局
- Miscarriage rate(5 years)
- Live birth rate(5 years)