NCT04743167Active, not recruiting
IVF Versus Surgery for Endometriosis Related Infertility
IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis
Source: ClinicalTrials.gov · Last updated 7 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 206 (estimated)
- First submitted
- 2 Feb 2021
- Start date
- 16 Mar 2021
- Primary completion date
- 30 Sept 2025
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Diseases
- Endometriosis
- NCT number
- NCT04743167
What you commit to
- Study type: Interventional
- Planned participants: 206
- From 16 Mar 2021 to the primary completion date, 30 Sept 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous surgery for endometriosis
- Previous IVF cycles
Other illness
- Doubtful sonographic findings that do not allow to reliably rule out malignancy.
Other
- Contraindication to pregnancy
- Hydrosalpinx
- Endometriomas with a mean diameter \> 4 cm
- Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
- Obstacles to regular sexual intercourses (sexual disturbances or logistic problems)
Who the study is looking for
- 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
Age in the registry: 18 years to 39 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.