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Active, Not Recruiting

NCT Number: NCT04743167

IVF Versus Surgery for Endometriosis Related Infertility

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni, Milan, MI, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Surgery

Procedure

Laparoscopic treatment of endometriotic lesions

IVF

Procedure

Up to three completed cycles of IVF

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Other

Collaborators

  • ASST Fatebenefratelli Sacco
  • IRCCS San Raffaele
  • Ministero della Salute, Italy

Registry information

Official study title

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

Acronym: SVIDOE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Feb 8, 2021
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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