Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Location contact
ANTONIA CARLA TESTA, Professor
CONTACT
Antonia Carla Testa, prof
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07587580
Fetal ovarian cysts are common prenatal findings with a highly variable clinical course, ranging from spontaneous resolution to complications such as torsion, hemorrhage, or rupture requiring surgery. Current prenatal classification is mainly based on the distinction between "simple" and "complex" cysts; however, this approach may be insufficient to accurately predict outcomes and guide perinatal management.
This multicenter prospective observational study aims to validate a management model based on the International Ovarian Tumor Analysis (IOTA) terminology for ultrasound characterization of fetal ovarian cysts. Pregnant women carrying a fetus with an ovarian cyst will be enrolled and followed with serial ultrasound examinations during pregnancy and after birth. Cysts will be classified according to morphology and cyst content (anechoic, low-level, ground-glass, hemorrhagic, mixed, and others) and managed according to a predefined protocol based on cyst size and ultrasound features.
The primary objective is to assess the rate of complications requiring postnatal surgery in conservatively managed fetal ovarian cysts with anechoic or low-level cystic content smaller than 4 cm. Secondary objectives include evaluation of complication rates in larger cysts managed with aspiration procedures, rates of spontaneous cyst resolution, rates of ovarian torsion, and the presence of normal ovarian parenchyma at histology in surgically treated cases.
The study aims to improve prenatal risk stratification and optimize perinatal management in order to reduce unnecessary surgery and preserve ovarian function.
Trial opening soon.
Get Notified18 year and older
Female
Observational
Roma, 00168, Italy
ANTONIA CARLA TESTA, Professor
CONTACT
Antonia Carla Testa, prof
PRINCIPAL_INVESTIGATOR
Only the study team can determine whether someone qualifies for participation.
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
Time frame: From enrollment through 2 weeks postnatal follow-up
Proportion of fetal ovarian cysts with anechoic or low-level content and diameter <4 cm at enrollment that develop complications requiring postnatal surgical intervention, including changes in cyst morphology during pregnancy or after birth.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Fetal Ovarian Cysts: Application of the International Ovarian Tumor Analysis (IOTA) Terminology and Implications for Perinatal Management
Acronym: F-IOTA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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