IVF Versus Surgery for Endometriosis Related Infertility (SVIDOE)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Procedure: IVF; Procedure: Surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04743167

ENDO-2020-23670289

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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206 participants in 2 patient groups

Surgery

Active Comparator group

Description:

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

Treatment:

Procedure: Surgery

In Vitro Fertilization

Active Comparator group

Description:

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)

Treatment:

Procedure: IVF