Randomized trial of autologous ovarian graft to preserve ovarian function in young women undergoing pelvic radiotherapy for cervical cancer
To evaluate the short-term feasibility and efficacy of fresh autologous ovarian tissue grafting into the subcutaneous tissue for the prevention of hypoestrogenism in young women with cervical cancer undergoing pelvic radiotherapy. Single center, nonblinded, exploratory phase II randomized trial conducted at Instituto do Câncer do Estado de São Paulo, Brazil, from June 2022 to April 2025. Women aged ≤35 years with locally advanced cervical cancer (FIGO 2018 stages IB3-IVA), preserved ovarian function, and histologic subtypes of squamous cell carcinoma or usual adenocarcinoma, eligible for definitive pelvic radiotherapy. Participants were randomized 1:1 to an intervention group (n = 12) with underwent autologous fresh ovarian tissue grafting into the subcutaneous tissue prior to pelvic radiotherapy, or to a control group (n = 10), with did not undergo grafting. Hormonal ovarian function assessed by serum estradiol and follicle-stimulating hormone (FSH) levels. A total of 22 patients were enrolled, with three excluded from the intervention group due to clinical conditions. The median follow-up was 18.9 months. At six months, 85% of patients in the intervention group maintained hormonal profiles consistent with preserved ovarian function and were free of climacteric symptoms, whereas all controls exhibited profiles compatible with premature ovarian insufficiency. Baseline assessments confirmed normal ovarian function in all participants. Fresh autologous subcutaneous ovarian grafting was technically safe, feasible and effective in preventing hypoestrogenism and climacteric symptoms during short-term follow-up in young women undergoing pelvic radiotherapy for cervical cancer.