Abstract / Summary
Introduction: Uterine fibroids represent the most common benign tumours in women of reproductive age and may impair reproductive function. Approximately 30% of infertile patients require myomectomy. However, evidence supporting the conventional postoperative interpregnancy interval (IPI) is not individualised, potentially resulting in unduly delayed childbearing for some women. Currently, no definitive clinical guidelines exist regarding the optimal IPI following myomectomy. After imaging confirmation at 6 months postoperatively showing no evidence of poor scar healing, this study will randomise patients who have undergone myomectomy to compare the safety and efficacy of a shortened pregnancy interval of 6 months with the conventional 12-month interval.
Methods and analysis: This multicentre randomised controlled trial will be conducted in Shanghai from 24 November 2025 to 31 August 2028, with the recruitment period running concurrently. A total of 384 women of reproductive age with Federation of Gynecology and Obstetrics type I-VI uterine fibroids, who have undergone myomectomy and express a clear immediate desire for conception, will be enrolled. Following provision of informed consent, and postoperative imaging at 6 months confirming satisfactory scar healing, eligible participants will be randomly allocated in a 1:1 ratio to either the shortened IPI group or the conventional IPI group. The primary outcome is the incidence of adverse pregnancy outcomes associated with myomectomy. The secondary outcomes include cumulative live birth rate, fibroid recurrence rate and obstetric complications.
Ethics and dissemination: The study protocol has been approved by the Institutional Review Boards of the Obstetrics and Gynecology Hospital of Fudan University, the Shanghai First Maternity and Infant Hospital and the China Welfare Institute International Peace Maternity and Child Health Hospital (approval number: GKLW-A-2025-108-01). Written informed consent will be obtained from all participants. The primary results of this trial will be submitted for publication in a peer-reviewed scientific journal. Following the publication, a lay summary of the main findings will be prepared and disseminated to all participants who request it.
Trial registration number: ChiCTR2500112650.