Imaging-guided shortened interpregnancy interval following myomectomy in China: protocol for a multicentre prospective randomised controlled trial

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.