Impact of prophylactic bilateral salpingectomy on ovarian reserve in women undergoing vaginal hysterectomy: A randomized controlled trial

Aim: The purpose of this study was to evaluate whether bilateral opportunistic salpingectomy (BOS) in premenopausal women has any detrimental effect on ovarian reserve (OR) and if this increases surgical consequences in women undergoing vaginal hysterectomy (VH)/Non-Descent vaginal hysterectomy (NDVH).Materials and Methods: This prospective, open-label, randomized, multisite, parallel group, concealed allocation, superiority trial was conducted at Benha University Hospital (BUH), and two private centers in El-Qalubia, Egypt, From September 2015 to September 2017. 110 women undergoing VH/NDVH were allocated to adding BOS (intervention group) or not (control group) at 1 : 1 ratio. The primary outcomes were differences in change of serum Anti-mullerian hormone (ΔAMH), serum follicular stimulating hormone (ΔFSH), antral follicular count (ΔAFC), flow index (ΔFI) vascularization index (Δ VI), vascularization flow index (Δ VFI) and calculated ovarian age with OvAge (Δ OvAge), measured preoperatively and at 6 to 8 months postoperatively. The secondary outcomes were surgical outcomes as well as the feasibility of performing BOS at VH/NDVH and hospital stay.Results: Baseline demographic, clinical, hormonal and three-dimensional ultrasound characteristics did not show significant differences between both groups according to both intention to treat (ITT) analysis as well as per protocol (PP) analysis. Also, the groups did not differ significantly regarding operative outcomes such as operative time, operative bleeding and hospital stay according to ITT and PP analyses. The BOS was surgically feasible in 95% (58/61) of tried cases. In both groups the postoperative AMH, AFC, VI, FI, VFI were decreased, while FSH, OvAge were increased. There were no statistically significant differences between intervention and control groups according to ITT as well as PP analyses regarding Δ AMH (P = 0.17), Δ FSH (P = 0.11), ΔAFC (P = 0.07), Δ VI (P = 0.82), Δ FI (P = 0.94),ΔVFI 9 (P = 0.96) and Δ OaAge (P = 0.78).Conclusion: Performing bilateral opportunistic salpingectomy at time of vaginal hysterectomy / Non-descent vaginal hysterectomy did not have a detrimental effect on ovarian reserve as well as surgical consequences when compared with a policy of performing hysterectomy alone. So adding BOS as ovarian cancer risk-reducing surgery appears to be a safe procedure in average OvCa risk premenopausal women undergoing VH/NDVH for benign gynecological indications.