IVF Versus Surgery for Endometriosis Related Infertility

NCT04743167 | Active Not Recruiting DMC

• 1 other identifier: ENDO-2020-23670289
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 3

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.

Conditions

Endometriosis

Keywords

IVF; surgery; endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

  up to 12 months since randomization

Secondary Outcomes (2)

• Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis

  12 months

• Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV).

  3 months

Study Arms (2)

Surgery

ACTIVE COMPARATOR

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

In Vitro Fertilization

ACTIVE COMPARATOR

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

Interventions

Surgery PROCEDURE

Laparoscopic treatment of endometriotic lesions

Surgery

IVF PROCEDURE

Up to three completed cycles of IVF

In Vitro Fertilization

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• IRCCS San Raffaele: collaborator
• ASST Fatebenefratelli Sacco: collaborator
• Ministero della Salute, Italy: collaborator

Study Sites (3)

ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni

Milan, MI, 20100, Italy

Location

IRCCS San Raffaele

Milan, MI, 20100, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

Location

Related Publications (1)

• Ottolina J, Vignali M, Papaleo E, Vigano P, Somigliana E, Ferrari S, Liprandi V, Belloni G, Reschini M, Candiani M, Vercellini P, Benaglia L. Surgery versus IVF for the treatment of infertility associated to ovarian and deep endometriosis (SVIDOE: Surgery Versus IVF for Deep and Ovarian Endometriosis). Clinical protocol for a multicenter randomized controlled trial. PLoS One. 2022 Aug 3;17(8):e0271173. doi: 10.1371/journal.pone.0271173. eCollection 2022.

  PMID: 35921357 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Laura Benaglia, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: March 16, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)