St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Rate of recruitment
研究概览
简要总结
The main causes of death in women are conditions affecting the heart and blood vessels (cardiovascular disease, CVD). Women who have difficulties getting pregnant (infertility) may be at increased risk, but the reasons for this are not clear. Infertility itself may be linked with poorer heart and blood vessel health, or fertility treatments such as in vitro fertilisation (IVF) could increase the risk.
The study aims to understand the practicalities of obtaining detailed profiling of women's pre- and post- pregnancy heart, blood vessel and metabolic health. Two groups of women in Manchester University NHS Foundation Trust, will be recruited over 2 years: 1) women planning a pregnancy, either spontaneously or with IVF treatment after infertility, 2) women who previously took part in a pregnancy health study after IVF or non-IVF conception.
Participants will attend a single research appointment where they will undergo a cardiometabolic health assessment. They will have their BMI calculated, body composition measured, a measurement of how well their blood vessels work using a blood pressure cuff around the arm and/or finger and blood sampling performed. A blood pressure cuff as well as a blood sugar sensor may be fitted to be worn after the appointment. Participants will be asked to complete a questionnaire(s), with follow-up for up to 13 months.
The cardiometabolic health of those who conceived with or without IVF treatment and with or without a history of infertility will be compared at both time points to investigate the possibility of links between infertility, IVF processes and CVD risk and to understand any potential barriers to recruitment of individuals at either time point to guide future studies. This information could then be used in a full-scale study, including in pregnancy, to improve care and promote lifelong health for women with infertility.
详细描述
Objectives:
Primary objective: To assess the feasibility of a pre-conception and postnatal cardiometabolic health research study in infertile and fertile individuals.
Secondary objectives:
- To assess clinic-measured cardiometabolic status
- To measure ambulatory cardiovascular status
- To measure ambulatory blood glucose concentrations
- To assess the views of fertile and infertile individuals on cardiometabolic health optimisation and research in this area
- To assess acceptability of cardiometabolic status measurement approaches (clinic and ambulatory measured) in fertile and infertile populations
- To conduct initial exploratory investigations into whether cardiometabolic status is influenced by a history of infertility
Study Design This is a prospective observational cohort study consisting of two cohorts: a pre-conception cohort and a post-pregnancy cohort made up of individuals with and without a history of infertility. All participants of either cohort will have one research visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •In pre-conception cohort:
- •Aged between 16 and 45
- •Able to provide informed consent
- •Either: 1) Those with a history of infertility (failure to conceive after at least 1 year of unprotected intercourse/3-6 cycles of Intra-Uterine Insemination (IUI) or diagnosed cause of infertility) and accepted for IVF at The Department of Reproductive Medicine, MFT or, 2) attending for a pre-conception appointment at MFT
- •Nulliparous (no previous pregnancies beyond 20 weeks)
- •No pre-existing heart disease, hypertensive disease, vascular disease or diabetes
- •In post-pregnancy cohort
- •Aged between 16 and 45
- •Able to provide informed consent
- •Participant of START clinic study (achieved pregnancy via a) IVF with or without ICSI treatment, b) spontaneous conception without medical intervention within 12 months, or c) spontaneous conception following ovulation induction for delay in spontaneous conception >12 months or confirmed anovulation)
排除标准
- •- In all participants:
- •Prisoners
- •Born male at birth
- •Language barrier not overcome by telephone or video interpretation services
- •Pregnant at time of study visit
- •Pre-conception participants only:
- •Accepted for IVF for non-infertility reasons i.e. egg donation, egg collection, egg banking, gestational surrogacy
研究组 & 干预措施
Post-pregnancy cohort
Individuals who participated in the START (St Mary's After Reproductive Technology) clinic study (20/NE/0220) who consented to receive future research invitations, will be invited to a research appointment 1-5 years post-birth.
Pre-conception: history of infertility cohort
Individuals with a history of infertility who have been accepted to undergo in vitro fertiliitsation (IVF) treatment (NHS or private funding) at the Department of Reproductive Medicine, Manchester University NHS Foundation Trust.
Pre- conception: no history of infertility cohort
Healthy individuals with no history of infertility, attending a pre-conception appointment at Manchester University NHS Foundation Trust.
结局指标
主要结局
Rate of recruitment
时间窗: Through study duration, approximately 23 months
Number of recruits
次要结局
- Recruitment acceptance(Through study duration, approximately 23 months)
- Time taken to achieve the proposed sample size(Recruitment period, approximately 23 months)
- Acceptance of the investigative methods(Through study duration, approximately 23 months)
- Duration of ambulatory monitoring(Up to 14 days post-study visit)
- Consent to data linkage(Through study duration, approximately 23 months)
- Participant questionnaire asking about importance of cardiometabolic health optimisation and research in this area(Through study duration, approximately 23 months)
- Participant questionnaire asking about acceptability of participation and of measurement techniques in the study(Through study duration, approximately 23 months)
- Variability between cohort differences in cardiometabolic health markers(Following analysis of data, an average of 3 years from study start)
- Proportion of pre-conception participants who conceive within a year of the study visit(A year after participant's study visit)
研究者
Lucy Higgins
Senior Clinical Lecturer and Honorary Consultant Obstetrician
University of Manchester