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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-45
SponsorUniversity of Manchester

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 3 trial groups
Group A: Pre-conception: history of infertility cohort
Group B: Pre- conception: no history of infertility cohort
Group C: Post-pregnancy cohort

Trial outcomes

Primary outcomes

1

Rate of recruitment

Number of recruits

Time frame
Through study duration, approximately 23 months

Secondary outcomes

1

Recruitment acceptance

Proportion of eligible individuals accepting recruitment

Time frame
Through study duration, approximately 23 months
2

Time taken to achieve the proposed sample size

Time taken to achieve the proposed sample size

Time frame
Recruitment period, approximately 23 months
3

Acceptance of the investigative methods

Proportion of individuals accepting each type of investigation

Time frame
Through study duration, approximately 23 months
4

Duration of ambulatory monitoring

Duration of ambulatory monitoring completed per participant

Time frame
Up to 14 days post-study visit

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: