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

Sponsor
University of Manchester
Study ID
NCT07173569
Status
Not Yet Recruiting

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Conditions

  • Assisted Reproductive Technology
  • Cardiovascular Health
  • Infertility
  • Maternal Cardiometabolic Health
  • Metabolic Health
  • in Vitro Fertilisation

Eligibility Criteria

Sex
FEMALE
Age
16 Years - 45 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Sep 15, 2025
Start date
May 1, 2026
Status verified
Sep 2025
Primary completion
Sep 30, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Rate of recruitment [ Time Frame: Through study duration, approximately 23 months ]

Central Contacts

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