IVF Versus Surgery for Endometriosis Related Infertility

Condition(s) studied

Investigational drug(s) / intervention(s)

Surgery: Laparoscopic treatment of endometriotic lesions

IVF: Up to three completed cycles of IVF

Study summary

The management of endometriosis-related infertility remains controversial. In particular, there is an equipoise for infertile women with endometriotic lesions detected at ultrasound. These women can be managed with either surgery or in vitro fertilization (IVF). The two approaches radically differ and they have never been compared with a randomized trial. As a consequence, affected women currently receive contrasting information and the mode of treatment substantially differ among centres, reflecting the local expertise of physicians rather than clinical needs.

The present study aims at clarify whether IVF could be superior to surgery in infertile women with endometriotic lesions detected at ultrasound. This topic will be addressed comparing the two approaches in terms of effectiveness and cost-effectiveness. In addition, the study will disentangling whether the endometriosis-related systemic inflammatory mechanisms may have an impact on the quality of folliculogenesis and on IVF outcomes. This specific objective will be pursued through the characterization and analysis of circulating extracellular vesicles (EV)-immunologic, proteomic and miRNA signatures and measurement of steroid hormones in follicular fluid.

Eligibility

Primary outcome measure(s)

• Live birth rate from pregnancies started within 12 months since randomization — up to 12 months since randomization
  to assess whether IVF is more effective than surgery in obtaining a live birth and, if so, what is the magnitude of this benefit

Trial sites (3)

More Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico trials in Italy

Other trials for the same condition