EndometriosisSVIDOENCT04743167
IVF Versus Surgery for Endometriosis Related Infertility
A study testing Surgery and IVF in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Surgery and IVF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 3 sitesItaly
- Study dates
- 16 Mar 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
Italy3 sites
ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni
Milan, MI, 20100
IRCCS San Raffaele
Milan, MI, 20100
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, 20122
About this study
Official title: IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis
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.
Read the detailed 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.
- Conditions
- Endometriosis
- Being tested
- Surgery, IVF
- Keywords
- IVF, surgery, endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Laparoscopic treatment of endometriotic lesions
IVFProcedure or surgery
Up to three completed cycles of IVF
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) Receives: Procedure: IVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 12 months since randomization
Secondary outcomes (2)
Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis
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.
Measured: 12 months
Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV).
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start16 Mar 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS San Raffaele, ASST Fatebenefratelli Sacco, Ministero della Salute, Italy
- Responsible party
- Sponsor
- Investigators
- Laura Benaglia, MD, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743167
- Sponsor's protocol ID
- ENDO-2020-23670289
- Acronym
- SVIDOE
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2021
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benaglia L, Vignali M, Reschini M, Vecchia ILA, Liprandi V, Ottolina J, Villanacci R, Buggio L, Papaleo E, Belloni G, Ferrari S, Vigano P, Vercellini P, Somigliana E, Candiani M. IVF versus surgery for infertility in women with deep and ovarian endometriosis: a partially randomized patient preference trial. Am J Obstet Gynecol. 2026 Oct 24:S0002-9378(26)00593-4. doi: 10.1016/j.ajog.2026.10.024. Online ahead of print.
PubMed 42925945Ottolina 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.
PubMed 35921357
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVF Versus Surgery for the Treatment of Infertility Associated to Ovarian and Deep Peritoneal Endometriosis
- ClinicalTrials.gov ID
- NCT04743167
- Acronym / sponsor ID
- SVIDOE / ENDO-2020-23670289
- Conditions
- Endometriosis
- Keywords
- IVF, surgery, endometriosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- IRCCS San Raffaele, ASST Fatebenefratelli Sacco, Ministero della Salute, Italy
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery | Active comparator | Procedure: SurgeryPatients undergoing surgery for endometriosis, after surgery, will receive indications for seeking for a natural pregnancy up to 12 months from the time of randomization |
| In Vitro Fertilization | Active comparator | Procedure: IVFPatients included in the IVF arm will undergo three complete cycles of IVF (i.e. three oocytes retrievals regardless of the number of embryo transfers) |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Previous surgery for endometriosis
- Previous IVF cycles
- Contraindication to pregnancy
- Hydrosalpinx
- Endometriomas with a mean diameter > 4 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryLaparoscopic treatment of endometriotic lesions | Procedure or surgery | Surgery |
| IVFUp to three completed cycles of IVF | Procedure or surgery | In Vitro Fertilization |
Primary outcome
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
2 secondary outcomes
Cost-effectiveness evaluation of the two different approaches in the treatment of endometriosis
Time frame: 12 months
Detachment of inflammatory mediators that might interfere with IVF through analysis of extracellular vescicles (EV).
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Derived from this study: PubMed 42925945Benaglia L, Vignali M, Reschini M, Vecchia ILA, Liprandi V, Ottolina J, Villanacci R, Buggio L, Papaleo E, Belloni G, Ferrari S, Vigano P, Vercellini P, Somigliana E, Candiani M. IVF versus surgery for infertility in women with deep and ovarian endometriosis: a partially randomized patient preference trial. Am J Obstet Gynecol. 2026 Oct 24:S0002-9378(26)00593-4. doi: 10.1016/j.ajog.2026.10.024. Online ahead of print.
- Derived from this study: PubMed 35921357Ottolina 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.
- Individual participant dataSharing planned: No
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Benaglia, MD principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and IVF in people with Endometriosis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate from pregnancies started within 12 months since randomization (time frame: up to 12 months since randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04743167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.