Reproductive outlook for women trying to conceive after medical or surgical treatment for endometriosis
La Prognosi Riproduttiva Nelle Donne Che Ricercano Prole Dopo Terapia Medica o Chirurgica Per Endometriosi: Studio Multicentrico Italiano
This study will try to see whether women treated medically or surgically for endometriosis are more likely to need medically assisted reproduction (PMA) and how their conception and pregnancy outcomes compare.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Academic / other |
| Locations | 1 site (Milan, MI, Italia) |
| Trial ID | NCT07437742 on ClinicalTrials.gov |
What this trial studies
This is an observational multicenter Italian study of women under 40 with a prior ultrasound or surgical diagnosis of endometriosis who sought offspring. Researchers will compare how often women go on to use PMA after medical treatment versus after surgical treatment and will describe modes of conception, pregnancy rates, and live births. The study will also compare post-surgical PMA pregnancy rates observed here with those from a previous single-center cohort to evaluate changes over about 15 years. Data will be collected pseudonymously from participating endometriosis referral centers, with the lead site in Milan.
Who should consider this trial
Good fit: Women under 40 with a prior ultrasound or surgical diagnosis of endometriosis from a participating referral center who are actively trying to conceive and consent to pseudonymised data use.
Not a fit: Women aged 40 or older, those without endometriosis, those who have had demolition surgery, those not seeking offspring, or couples with severe male factor infertility are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help doctors and patients better predict the chance of needing PMA and the likelihood of pregnancy after medical or surgical treatment, improving counseling and treatment choices.
How similar studies have performed: Previous single-center and cohort studies have reported mixed results on pregnancy after surgery and assisted reproduction, but large multicenter comparisons of medical versus surgical management in relation to PMA use remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Milan, MI, Italia
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan, MI, Italia, Italy (Recruiting)
Study contacts
- Study coordinator: Nicola Dr Berlanda, principal investigator
- Email: nicola.berlanda@policlinico.mi.it
- Phone: +39 0255031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.