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ACTIVE NOT RECRUITING
NCT04743167
NA

IVF Versus Surgery for Endometriosis Related Infertility

Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

View on ClinicalTrials.gov

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.

Official title: IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis

Key Details

Gender

FEMALE

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

206

Start Date

2021-03-16

Completion Date

2025-12-31

Last Updated

2025-02-07

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Surgery

Laparoscopic treatment of endometriotic lesions

PROCEDURE

IVF

Up to three completed cycles of IVF

Locations (3)

ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni

Milan, MI, Italy

IRCCS San Raffaele

Milan, MI, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, Italy