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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
Sponsor:
Collaborators:
IRCCS San Raffaele
ASST Fatebenefratelli Sacco
Ministero della Salute, Italy
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief 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.


Condition or disease Intervention/treatment Phase
Endometriosis Procedure: Surgery Procedure: IVF Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Procedure: Surgery
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)
Procedure: IVF
Up to three completed cycles of IVF




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age < 40 years
  • Pregnancy seeking for more than 12 months
  • Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days
  • Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.
  • Normal seminal analysis based on WHO criteria
  • Absence of ureteral stenosis or intestinal subocclusive symptoms

Exclusion Criteria:

  • Previous surgery for endometriosis
  • Previous IVF cycles
  • Contraindication to pregnancy
  • Hydrosalpinx
  • Endometriomas with a mean diameter > 4 cm
  • Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
  • Doubtful sonographic findings that do not allow to reliably rule out malignancy.
  • Obstacles to regular sexual intercourses (sexual disturbances or logistic problems)

Information from the National Library of Medicine

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


Contacts
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Contact: Laura Benaglia, MD +390255034303 laura.benaglia@policlinico.mi.it
Contact: Marco Reschini, MSc +390255034303 marco.reschini@policlinico.mi.it

Locations
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Italy
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    laura.benaglia@policlinico.mi.it   
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IRCCS San Raffaele
ASST Fatebenefratelli Sacco
Ministero della Salute, Italy
Investigators
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Principal Investigator: Laura Benaglia, MD Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT04743167    
Other Study ID Numbers: ENDO-2020-23670289
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
IVF
surgery
endometriosis
Additional relevant MeSH terms:
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Infertility
Endometriosis