How to Reduce Bone Mineral Density Loss During Treating Endometriosis? Protocol of a Double-blinded, Double-doomy, Randomized Controlled trial

Abstract Introduction: Endometriosis is manifested with irregular menstruation, dysmenorrhea and infertility. Laparoscopy is the main treatment for endometriosis, but it is also characterized by high recurrence rates if not treated with medication after the surgery. Leuprolide acetate (LA) could prevent the recurrence of endometriosis after laparoscopy, but the long-term use of LA can cause irreversible bone mineral density (BMD) loss. Add-back therapy is an improved scheme for the treatment of endometriosis with GnRH-a, which can eliminate or reduce the side effects while retain the therapeutic effect by controlling estrogen within a certain range to maintain BMD. We try to conduct a double-blinded, double-doomy, randomized controlled trial to evaluate the efficacy and safety of LA plus Tibolone add-back therapy in reducing BMD loss of endometriosis after laparoscopy. Methods: Patients will be randomly allocated to the treatment group (LA plus Tibolone) or control group (LA plus Caltrate) in a 1:1 ratio. The outcomes are BMD, the recurrence of endometriosis, estradiol, follicle-stimulating hormone, luteinizing hormone, Kupperman score, and incidence of complications. SPSS version 22 will be used for the data. Conclusions: The findings of the study will be help to evaluate the efficacy and safety of LA plus Tibolone add-back therapy in reducing BMD loss of endometriosis after laparoscopy.