Effect of opportunistic salpingectomy at hysterectomy on anti-Müllerian hormone: A substudy of a randomized trial.

INTRODUCTION

Opportunistic salpingectomy during benign hysterectomy with ovarian preservation has become a preventive approach to epithelial ovarian cancer, particularly high-grade serous carcinoma, given evidence that it originates in the Fallopian tubes. However, the long-term impact of the procedure on ovarian function remains unknown. This study assessed whether opportunistic salpingectomy at benign hysterectomy affects ovarian function compared with no salpingectomy 1 year after surgery.

MATERIAL AND

METHODS

This is a noninferiority substudy of the national register-based randomized controlled trial HOPPSA (Hysterectomy and OPPortunistic SAlpingectomy), registered at clinicaltrials.gov (NCT03045965) on 8 February 2017. Women under 55 years planned for a benign hysterectomy at the Sahlgrenska University Hospital were randomized to hysterectomy with opportunistic salpingectomy or hysterectomy-only. Blood samples were collected preoperatively and 1 year postoperatively and analyzed for anti-Müllerian hormone (AMH) by Access2 immunoassay. The primary outcome was absolute change in AMH over time in the per-protocol population. Secondary outcomes were the relative change in AMH and level of AMH 1 year after surgery. The difference between groups was estimated by analysis of covariance, adjusted for baseline AMH, age groups, operative route, and time from surgery to second sampling. Multiple imputation was applied on missing samples. The noninferiority margin was set to 0.125 μg/L.

RESULTS

Between 16 August 2018 and 6 September 2023, 89 women were randomized to hysterectomy with opportunistic salpingectomy (n = 46) or hysterectomy-only (n = 43). After exclusions due to prior ovarian surgery or not receiving the allocated surgery, 37 women were analyzed in each group. Mean age was 45.1 and 46.3 years in respective groups and mean body mass index was 29.5 and 27.2 kg/m2. Baseline characteristics did not differ between the groups. Both groups had reduced AMH levels 1 year postoperatively. The adjusted mean difference in the reduction was -0.03 μg/L (95% CI -0.23 to 0.18), with 0.18 exceeding the predefined noninferiority limit.

CONCLUSIONS

Noninferiority was not demonstrated for opportunistic salpingectomy at hysterectomy compared with hysterectomy-only regarding ovarian function assessed by AMH. Absolute reduction in AMH levels appeared to be similar in both groups, with an unexpectedly large variability in AMH reduction suggesting a more pronounced decline in some individuals.