Surgery versus IVF for the treatment of infertility associated to ovarian and deep endometriosis (SVIDOE: Surgery Versus IVF for Deep and Ovarian Endometriosis). Clinical protocol for a multicenter randomized controlled trial

Abstract

The management of endometriosis-related infertility is still a challenging issue. Women can be managed with either surgery or in vitro fertilization (IVF). The decision is tailored to the patients considering pros and cons of both approaches. Surgery might increase the chances of natural conception and relieve symptoms. IVF may be more effective, but costs are higher and unoperated women face some peculiar additional risks during the procedure and pregnancy. The unavailability of randomized trials comparing the two strategies hampers the possibility to provide precise estimates. This Randomized Controlled Trial (RCT) aims at filling this gap. This is a multicenter, non-blinded, randomized controlled trial with parallel groups and allocation 1:1. Three Italian Academic Infertility Units will be involved. Main inclusion criteria are infertility for more than one year, age less than 40 years and a sonographic diagnosis of endometriosis (ovarian endometriomas or deep peritoneal lesions). Previous IVF and previous surgery for endometriosis are exclusion criteria. Women will be randomized to either surgery and then natural pregnancy seeking or a standard program of three IVF cycles. The primary aim is the comparison of live birth rate between the two groups (IVF versus surgery) within one year of randomization. The secondary aim is the evaluation of cost-effective profile of the two interventions. The present study can influence the clinical practice of infertility treatment in women with endometriosis. From a public health perspective, information on the more cost-effective clinical management strategy would consent a wiser allocation of resources. Trial registration: NCT04743167, registered on 8 February 2021.

First-line surgery versus first-line assisted reproductive technology for women with deep infiltrating endometriosis: a systematic review and meta-analysis

“…Instead, individualized treatment plans, considering patient’s specific circumstances and preferences, should be the goal. Currently ongoing multicentric trials may provide deeper understanding of the comparative effectiveness of the different treatment options, including surgery and ARTs ( 27 ).…”

Live Birth After Oocyte Donation In Vitro Fertilization Cycles in Women With Endometriosis

“…Endometriosis affects 10% to 15% of women of reproductive age, and up to 25% to 50% of women with infertility have endometriosis . Currently, in women affected, infertility can be managed with either surgery or assisted reproduction technology (ART) . In women with endometriosis who undergo autologous in vitro fertilization (IVF) procedures, success rates have been reported to be lower compared with women without the disease .…”

“… 1 , 2 , 3 , 4 Currently, in women affected, infertility can be managed with either surgery or assisted reproduction technology (ART). 5 In women with endometriosis who undergo autologous in vitro fertilization (IVF) procedures, success rates have been reported to be lower compared with women without the disease. 3 An increased risk of unexpected poor response to ovarian stimulation and a lower number of retrieved oocytes beyond the well-known detrimental effects of surgery for ovarian endometriomas have been associated with the disease.…”