An interventional study of Surgery and IVF in Endometriosis, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Active, not recruiting at 3 sites in Italy. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Not applicable, Interventional, and Treatment
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.
Women accepting to enter the study will be randomized to either surgery and then natural pregnancy seeking or a program of three complete IVF cycles (i.e. three oocytes retrievals regardless of the number of embryo transfers performed). The initial time point will be the time of randomization. Women of both study groups will initiate treatment (surgery or IVF) in a shortest delay, maximum 3 months. Only live birth pregnancies and initiating within a 12-months period starting from this time point will be included in the primary outcome.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 206 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 214 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
Patients undergoing surgery for endometriosis, after surgery, will receive indications for seeking for a natural pregnancy up to 12 months from the time of randomization
Procedure: Surgery
Patients included in the IVF arm will undergo three complete cycles of IVF (i.e. three oocytes retrievals regardless of the number of embryo transfers)
Procedure: IVF
Laparoscopic treatment of endometriotic lesions
Up to three completed cycles of IVF
Live birth rate from pregnancies started within 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
Time frame: up to 12 months since randomization
Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis
to assess whether or not IVF is more cost-effective than surgery. To this aim, costs will be calculated based on the local charges for treatments (Diagnostic-related groups) and the costs of drugs supported by the public health system. The perspective will be the one of the public health provider.
Time frame: 12 months
Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV).
to understand whether the endometriosis-related systemic inflammatory milieu demonstrated by the presence of circulating EVs characterized by an inflammatory signature may influence the folliculogenesis quality and IVF outcomes. EVs will be assessed by: Nanoparticle Tracking analysis (NTA) to determine their total values and their distribution; specific markers for the various lymphocyte populations by flow cytometry to assess the immunological origin; miRNA profile and proteomic analysis.
Time frame: 3 months
Plan to share: No
This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico