Status:
NOT_YET_RECRUITING
St Mary's Assisted Reproductive Technology and Cardiometabolic Health: Modifiable Targets for Multimorbidity Prevention (START-HEALThY)
Lead Sponsor:
University of Manchester
Conditions:
Maternal Cardiometabolic Health
Infertility
Eligibility:
FEMALE
16-45 years
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 ris...
Detailed Description
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 ass...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07173569
Start Date
November 1 2025
End Date
October 31 2028
Last Update
September 15 2025
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