Role of intrauterine balloon stent or oral estrogen on prevention of adhesion after hysteroscopic septectomy in septate uterus: study protocol for a randomized controlled multi-center study in China

• BackgroundThe septate uterus is the most common uterine malformation. The uterus septum increases the possibility of adverse pregnancy outcomes which can be improved by hysteroscopic metroplasty (trans-cervical resection of septate, TCRS). Various methods are used to prevent postoperative intrauterine adhesion in clinical practice. However, there is insufficient evidence to support or oppose the use of any of them. This study will be a multi-center, open labeled, prospective, randomized, controlled study. We will examine whether it is necessary to use the anti-adhesion barrier or a certain dose estrogen to prevent intrauterine adhesion after TCRS and further improve the fertility outcome.• MethodsA total of 243 patients with septate uterus who meet the inclusion criteria will be randomly assigned into three groups with 1:1:1 allocation ratio. Group A will be the control group without any application of anti-adhesion method after TCRS; the participants in group B will be inserted an intrauterine balloon stent after TCRS for one week; the participants in group C will take estradiol valerate (2mg, bid) for 2 months after the surgery. A second-look hysteroscopy will be carried out after two menstrual cycles after the surgery to evaluate the intrauterine condition. Pregnancy outcomes, particularly the live birth rate, will be followed for at least one year.• DiscussionThis study will be the first well-powered clinical trial to assess the effectiveness of the anti-adhesion barrier or a certain dose of estrogen to prevent intrauterine adhesion after TCRS and further improve the fertility outcome. Our findings will guide the clinical care of patients after TCRS.Trial registration: ChiCTR, ChiCTR2000032061. Registered on Apr 19, 2020, http://www.chictr.org.cn/showproj.aspx?proj=52499