IVF Versus Surgery for Endometriosis Related Infertility (SVIDOE)
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|ClinicalTrials.gov Identifier: NCT04743167|
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : April 22, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Procedure: Surgery Procedure: IVF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis|
|Actual Study Start Date :||March 16, 2021|
|Estimated Primary Completion Date :||April 30, 2024|
|Estimated Study Completion Date :||January 31, 2025|
Active Comparator: Surgery
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
Laparoscopic treatment of endometriotic lesions
Active Comparator: In Vitro Fertilization
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)
Up to three completed cycles of IVF
- Live birth rate from pregnancies started within 12 months since randomization [ Time Frame: 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
- Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis [ Time Frame: 12 months ]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.
- Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV). [ Time Frame: 3 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04743167
|Contact: Laura Benaglia, MDfirstname.lastname@example.org|
|Contact: Marco Reschini, MScemail@example.com|
|ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni||Recruiting|
|Milan, MI, Italy, 20100|
|Contact: Michele Vignali, MD|
|IRCCS San Raffaele||Recruiting|
|Milan, MI, Italy, 20100|
|Contact: Jessica Ottolina, MD|
|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico||Recruiting|
|Milan, MI, Italy, 20122|
|Contact: Laura Benaglia, MD +390255034303 firstname.lastname@example.org|
|Principal Investigator:||Laura Benaglia, MD||Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|