- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437742
Reproductive Prognosis in Women Seeking Offspring After Medical or Surgical Therapy for Endometriosis (SURGENDO)
February 24, 2026 updated by: Direzione Ginecologia, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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.
Study Overview
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 Type
Observational
Enrollment (Estimated)
650
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nicola Dr Berlanda, principal investigator
- Phone Number: +39 0255031
- Email: nicola.berlanda@policlinico.mi.it
Study Locations
-
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MI, Italia
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Milan, MI, Italia, Italy, 20077
- Recruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
-
Contact:
- Nicola Dr Berlanda
- Phone Number: +39 0255031
- Email: nicola.berlanda@policlinico.mi.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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)..
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2012 to 2021 diagnosis
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
March 30, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
October 15, 2024
First Submitted That Met QC Criteria
February 24, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 24, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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