Not Yet RecruitingNot Applicable

St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)

120 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range16 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: \- 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

What they're measuring

Rate of recruitment

Timeframe: Through study duration, approximately 23 months

Trial details

NCT IDNCT07173569

SponsorUniversity of Manchester

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-30

Contact for this trial

Lucy Higgins, MBChB PhD MRCOG

+44 0161705650 lucy.higgins@manchester.ac.uk