IVF Versus Surgery for Endometriosis Related Infertility

Last updated: February 5, 2025
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Endometriosis

Infertility

Treatment

IVF

Surgery

Clinical Study ID

NCT04743167
ENDO-2020-23670289
  • Ages 18-39
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 peritonealendometriosis.

  • Normal seminal analysis based on WHO criteria

  • Absence of ureteral stenosis or intestinal subocclusive symptoms

Exclusion

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 Design

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: IVF
Phase:
Study Start date:
March 16, 2021
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni

    Milan, MI 20100
    Italy

    Site Not Available

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, MI 20122
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Milan, MI 20100
    Italy

    Site Not Available

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