About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Prisoners
Born male at birth
Language barrier not overcome by telephone or video interpretation services
Pregnant at time of study visit
Trial population
There are two cohorts for this study: pre-conception and post-pregnancy. For the pre-conception cohort of the study, two groups of participants will be recruited: * Group 1: individuals with a history of infertility who have been accepted to undergo IVF treatment at the Department of Reproductive Medicine, MFT. * Group 2: individuals with no history of infertility, attending for a pre-conception appointment at MFT. For the post-pregnancy cohort of the study, 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 an research appointment at 1-5 years post-birth.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of recruitment
Number of recruits
Secondary outcomes
Recruitment acceptance
Proportion of eligible individuals accepting recruitment
Time taken to achieve the proposed sample size
Time taken to achieve the proposed sample size
Acceptance of the investigative methods
Proportion of individuals accepting each type of investigation
Duration of ambulatory monitoring
Duration of ambulatory monitoring completed per participant
Locations
Sponsors and contacts
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