IVF Versus Surgery for Endometriosis Related Infertility (SVIDOE)

February 5, 2025 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Milan, MI, Italy, 20100
        • IRCCS San Raffaele
      • Milan, MI, Italy, 20100
        • ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 12 months since randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

IRCCS San Raffaele
ASST Fatebenefratelli Sacco
Ministero della Salute, Italy

Investigators

  • Principal Investigator: Laura Benaglia, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2021

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 2, 2021

First Submitted That Met QC Criteria

February 5, 2021

First Posted (Actual)

February 8, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDO-2020-23670289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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