EndometriosisSURGENDONCT07437742
Reproductive Prognosis in Women Seeking Offspring After Medical or Surgical Therapy for Endometriosis
An observational study of Endometriosis and Fertility, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
The study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Endometriosis, Fertility
- What is being tested?
- PMA
- How many people
- 650 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2024to 31 Dec 2026
- Phase
- Observational
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with endometriosis with an ultrasound or surgical diagnosis of endometriosis in one of the centres participating in the study who sought a pregnancy after diagnosis at an age of less than 40 years. The number of patients required will be approximately 650 in order to detect an absolute difference of ≥10% between the two groups ( medical or surgery terapy)..
Who may be able to join
- age <40 years at the time of offspring research
- previous ultrasound or surgical diagnosis of endometriosis made in one of the endometriosis referral centres participating in the study
- search for offspring after diagnosis
- consent to the use of pseudonymised data for research purposes.
Who cannot join
- women without endometriosis
- age >=40 years at the time of the search for offspring
- women who have undergone demolition surgery
- women who do not wish to have offspring
- women who have not given consent for their pseudonymised data to be used for research purposes
- severe male infertility factor (testicular sperm retrieval)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italia, 20077
Nicola Dr Berlanda, +39 0255031, nicola.berlanda@policlinico.mi.it
About this study
Official title: La Prognosi Riproduttiva Nelle Donne Che Ricercano Prole Dopo Terapia Medica o Chirurgica Per Endometriosi: Studio Multicentrico Italiano
The study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis.
Read the detailed description
The objective of the study is to compare how many women with endometriosis undergo PMA after medical treatment and how many after surgical treatment , then compare these data with those reported in the literature. Secondary objectives will be to describe the mode of conception ande pregnancy rate and to compare the pregnancy rate from post-surgical PMA observed in the present Italian multicenter study with that observed in the previous single-center study conducted at the Foundation. This will allow to evaluate the impact of 15 years of evolution of surgical and PMA techniques on the reproductive prognosis of women operated for endometriosis and to expand the observation to the whole Italian territory.
- Conditions
- Endometriosis, Fertility
- Being tested
- PMA
- Keywords
- fertility, endometriosis, surgery, PMA
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMAOther
use of Medically assisted procreation techniques (PMA)
What is being measured
The primary outcome is the main question the study is designed to answer.
endometriosis and PMA
Compare the number of women who undergo PMA after medical treatment with those who undergo PMA after surgery, then compare these data with those reported in the literature
Measured: 2012 to 2021 diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Oct 2024
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Direzione Ginecologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437742
- Sponsor's protocol ID
- 4291
- Acronym
- SURGENDO
- Status last verified
- Feb 2026
- First submitted
- 15 Oct 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Somigliana E, Daguati R, Vercellini P, Barbara G, Benaglia L, Crosignani PG. The use and effectiveness of in vitro fertilization in women with endometriosis: the surgeon's perspective. Fertil Steril. 2009 May;91(5):1775-9. doi: 10.1016/j.fertnstert.2008.02.004. Epub 2008 Apr 3.
PubMed 18394620
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- La Prognosi Riproduttiva Nelle Donne Che Ricercano Prole Dopo Terapia Medica o Chirurgica Per Endometriosi: Studio Multicentrico Italiano
- ClinicalTrials.gov ID
- NCT07437742
- Acronym / sponsor ID
- SURGENDO / 4291
- Conditions
- Endometriosis, Fertility
- Keywords
- fertility, endometriosis, surgery, PMA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2026 (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 study aims to compare the percentage of women with endometriosis who undergo PMA after medical vs surgical treatment and to describe conception patterns, pregnancy rates, and number of live vessels in women seeking offspring with endometriosis.
Detailed description
The objective of the study is to compare how many women with endometriosis undergo PMA after medical treatment and how many after surgical treatment , then compare these data with those reported in the literature. Secondary objectives will be to describe the mode of conception ande pregnancy rate and to compare the pregnancy rate from post-surgical PMA observed in the present Italian multicenter study with that observed in the previous single-center study conducted at the Foundation. This will allow to evaluate the impact of 15 years of evolution of surgical and PMA techniques on the reproductive prognosis of women operated for endometriosis and to expand the observation to the whole Italian territory.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with endometriosis with an ultrasound or surgical diagnosis of endometriosis in one of the centres participating in the study who sought a pregnancy after diagnosis at an age of less than 40 years. The number of patients required will be approximately 650 in order to detect an absolute difference of ≥10% between the two groups ( medical or surgery terapy)..
Key inclusion criteria (4 listed)
- age <40 years at the time of offspring research
- previous ultrasound or surgical diagnosis of endometriosis made in one of the endometriosis referral centres participating in the study
- search for offspring after diagnosis
- consent to the use of pseudonymised data for research purposes.
Key exclusion criteria (6 listed)
- women without endometriosis
- age >=40 years at the time of the search for offspring
- women who have undergone demolition surgery
- women who do not wish to have offspring
- women who have not given consent for their pseudonymised data to be used for research purposes
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 |
|---|---|---|
| PMAuse of Medically assisted procreation techniques (PMA) | Other | – |
Primary outcome
endometriosis and PMA
Time frame: 2012 to 2021 diagnosis
Compare the number of women who undergo PMA after medical treatment with those who undergo PMA after surgery, then compare these data with those reported in the literature
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 27 Feb 2026.
- Results publication: PubMed 18394620Somigliana E, Daguati R, Vercellini P, Barbara G, Benaglia L, Crosignani PG. The use and effectiveness of in vitro fertilization in women with endometriosis: the surgeon's perspective. Fertil Steril. 2009 May;91(5):1775-9. doi: 10.1016/j.fertnstert.2008.02.004. Epub 2008 Apr 3.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Fertility, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Nicola Dr Berlanda, principal investigator (+39 0255031, nicola.berlanda@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endometriosis and PMA (time frame: 2012 to 2021 diagnosis). 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 NCT07437742, which also lists 1 linked publication.
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 27 Feb 2026.