New ultrasound method may predict which ovarian cysts in unborn babies need surgery
NCT ID NCT07587580
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time
Summary
This study looks at a new way to classify ovarian cysts found in unborn babies using detailed ultrasound features. Researchers will follow 100 pregnant women whose fetuses have an ovarian cyst, tracking the cyst's size and appearance over time. The goal is to see if this classification can better predict which cysts will cause problems and need surgery after birth, potentially reducing unnecessary operations and preserving the ovary.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a more accurate way to predict which fetal ovarian cysts will resolve on their own, reducing unnecessary surgeries and preserving ovarian function.
- What could go wrong
- This is an observational study, not a treatment trial. It may not change current practice if the new classification does not improve outcomes. Results are preliminary and need further validation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Pregnant women with a prenatal ultrasound diagnosis of fetal ovarian cyst, recruited consecutively across participating centers, and followed prospectively from diagnosis until postnatal follow-up according to a standardized management protocol based on IOTA ultrasound classification.
- Ages
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18 years and older
- Sex
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Female participants only
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Pregnant women aged ≥18 years Singleton or multiple pregnancies with fetal ovarian cyst diagnosed by prenatal ultrasound at any gestational age Signed informed consent Exclusion Criteria: Refusal to provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy