The START clinic feasibility study: exploring the feasibility of prospective obstetric research with retrospective Artificial Reproductive Technologies (ART) data linkage

The START clinic study recruited 120 participants conceiving by assisted reproductive technologies or spontaneous conception (fresh embryo transfer in-vitro fertilisation (IVF) N=36, frozen embryo transfer N=62, spontaneous conception N=14, ovulation induction N=7). These participants were prospectively observed 4-6 weekly throughout pregnancy, with retrospective linkage to fertility treatment data where possible. The feasibility assessment explored acceptability, possibility and extent of retrospective data access as well as recruitment, retention and acceptability of research measures and observation. This data dictionary outlines routinely collected data taken during the START clinic study, including baseline data questions, consent, visit records, end of pregnancy data, fertility treatment data and questionnaires.

START诊所研究共招募120名参与者，均通过辅助生殖技术或自然受孕方式妊娠，其中体外受精（in-vitro fertilisation, IVF）新鲜胚胎移植36例、冷冻胚胎移植62例、自然受孕14例、诱导排卵7例。研究团队对所有参与者开展全孕期前瞻性随访，随访频次为每4至6周1次，并尽可能回溯关联其生育治疗相关数据。本次可行性评估探索了回溯性数据获取的可接受性、可行性与覆盖范围，同时调研了研究招募、受试者留存情况，以及研究测评与观察环节的受试者接受度。本数据字典梳理了START诊所研究中常规采集的全部数据，涵盖基线调研问题、知情同意相关内容、就诊记录、妊娠结局数据、生育治疗数据及各类问卷。