The START clinic: An observational feasibility study of prospective obstetric research with retrospective ART data linkage

Abstract Background: 1 in 39 UK babies are conceived using assisted reproductive technologies (ART). Pregnancy complications are more common following ART and may be further influenced by individual ART variables, with evidence linking suboptimal periconceptual/ intrauterine environment and adult cardiometabolic risk. However, high quality retrospective studies linking detailed ART variables and subsequent pregnancy outcomes are made more challenging by UK data-sharing restrictions and lack in-depth examination of maternofetal health. This study aimed to examine the feasibility of prospective observation of ART pregnancies and subsequent retrospective ART data linkage. Methods: The START clinic was a single-centre observational antenatal cohort study recruiting medically healthy participants with singleton pregnancies after IVF treatment, ovulation induction (OI) or spontaneous conception. Serial maternofetal assessments were made at 3-6 week intervals throughout pregnancy and at birth. Participants self-identified ART treatment centres and consented to fertility treatment data access, from which ART treatment details were extracted where possible. Recruitment, patient experience, uptake of consent for data access and optional maternofetal assessments, as well as the possibility of data access, were considered as part of the feasibility assessment. Results: 120 participants were recruited, 99 IVF-conceiving (36 fresh-ET, 62 frozen-ET, 1 unknown ET type) and 21 non-IVF-conceiving (7 OI, 14 spontaneous); 100% of participants were followed to delivery and 100% satisfaction reported. Consent to access fertility treatment data was obtained in 101/106 (95.3%) of ART-conceiving participants, and could be accessed from 3/16 fertility centres approached (one NHS, two private). Overall, ART treatment data could be linked to 57/101 (58%) of consenting study participants, and accuracy of participant-reported ART parameter data ranged from 98-100% when compared to ART treatment records. Conclusions: It is feasible and highly acceptable to patients to prospectively study ART pregnancies in the UK. Retrospective linkage to ART treatment records is possible but access is inconsistent; a prospective or participant-reported approach is recommended for future study designs. Such studies are needed to better understand the potential impacts of ART on mothers and fetuses, and to guide future ART practices, potentially reducing risk of future morbidity and mortality in the mother and offspring. Trial Registration: clinicaltrials.gov NCT04488861, registered on 23/7/2020