Introduction: The lifetime risk of women undergoing surgery for the presence of benign ovarian pathology in the united kingdom (UK) is 5-10%. Despite minimally invasive surgical techniques, evidence suggests a number of healthy ovarian follicles and tissues are resected intraoperatively, resulting in subsequent decline of ovarian reserve. As such, there is an increasing demand for the implementation of fertility preservation surgery (FPS). This study will evaluate the effect on ovarian reserve following two different surgical interventions for the management of benign ovarian cysts.
Methods and analysis: We will conduct a two-armed randomised controlled trial comparing laparoscopic ovarian cystectomy, considered gold standard treatment as per the Royal College of Obstetricians and Gynaecologists (RCOG) Green Top guidelines for the management of benign ovarian cysts, with ultrasound guided laparoscopic ovarian cystectomy (UGLOC), a novel method of FPS. The study commencement date was October 2021 and completion date October 2024. The primary outcome will be the difference in anti-Mullerian hormone (pmol/L) (AMH) and antral follicle count (AFC) measured 3 and 6 months post operatively from the pre-operative baseline. Secondary outcomes include assessment of various surgical and histopathological outcomes including: duration of hospital stay (days), duration of surgery (mins), presence of intra-operative cyst rupture (yes/no), presence of ovarian tissue within the specimen (yes/no) and the grade of follicles excised with specimen (grade 0-4). We aim to randomise 94 patients over 3 years to achieve power of 80% at an alpha level of 0.05.
Ethics and dissemination: Findings will be published in peer reviewed journals and presented at national and international conferences and scientific meetings. The Chelsea NHS Research and Ethics Committee have awarded ethical approval of the study (21/LO/036).
Trial registration number: NCT05032846