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

NCT07173569 | Not Yet Recruiting

• 1 other identifier: 351318
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Feasibility study; Ambulatory cardiometabolic health monitoring; Cohort

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment

  Number of recruits

  Through study duration, approximately 23 months

Secondary Outcomes (9)

• 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

Study Arms (3)

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.

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.

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Manchester: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum samples, with participant consent, will be retained for the length of the study.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Lucy Higgins, MBChB PhD MRCOG

CONTACT

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

Sarah Willetts, BMedSci MBChB

CONTACT

sarah.willetts@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinical Lecturer and Honorary Consultant Obstetrician

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: September 15, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2025-09