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

Jessica Ottolina, M. Vignali, Michele Vignali, Enrico Papaleo, Paola Viganò, Edgardo Somigliana, Stefano Ferrari, Valeria Liprandi, Gaia Maria Belloni, Gaia Belloni, Marco Reschini, Massimo Candiani, Paolo Vercellini, Laura Benaglia
PloS one · 2022 · vol. 17(8) , pp. e0271173 · doi:10.1371/journal.pone.0271173 · PMID:35921357 · PMC9348732 · W4289637506
article OA: gold CC0 ⤵ 11 in-corpus citations
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⚙ AI-generated summary by claude@2026-06, 2026-06-08 ⓘ

This multicenter randomized controlled trial will compare live birth rates and cost-effectiveness of surgery versus three IVF cycles for infertility in women with ovarian or deep endometriosis.

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⚙ AI-generated deep summary by claude@2026-06, 2026-06-09 ⓘ

This paper describes the protocol for a multicenter, non-blinded randomized controlled trial (SVIDOE) in women under 40 with infertility for more than one year, regular cycles, and a sonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis. Participants are randomized 1:1 to either surgery followed by attempts at natural conception or to a standard program of three complete IVF cycles, with the primary outcome being live birth within one year and a secondary outcome comparing cost-effectiveness from a health care system perspective. Key limitations acknowledged in the protocol include the non-blinded design and the lack of prior robust randomized evidence specifically for advanced endometriosis, which motivates the trial, while also noting that additional factors like adenomyosis presence will be recorded but will not change allocation. This paper is centrally about endometriosis — it develops a randomized trial protocol comparing surgery versus IVF for infertility associated with ovarian and deep endometriosis.

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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.

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Condition tags

endometriosisinfertility

MeSH descriptors

Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Endometriosis Infertility Infertility Infertility Infertility Infertility Infertility Infertility Infertility

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Papers in the corpus that this work cites (lower rings, blue) and that cite this one (upper rings, green). Dot size scales with the paper's in-corpus citation count — bigger dot = more influential within the endo/adeno field. Click a dot to open that paper. [ expand to 2 hops ] — adds papers reached through this work's immediate citers/citees. Heavier; up to 60 extra dots.

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