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Fetal Ovarian Cysts and IOTA Terminology for Perinatal Management

Fetal Ovarian Cysts: Application of the International Ovarian Tumor Analysis (IOTA) Terminology and Implications for Perinatal Management

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07587580
Acronym
F-IOTA
Enrollment
100
Registered
2026-05-14
Start date
2026-10-11
Completion date
2028-05-31
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Ovarian Cyst, Neonatal Ovarian Cyst

Brief summary

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.

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Complication Rate in Conservatively Managed Fetal Ovarian CystsFrom enrollment through 2 weeks postnatal follow-upProportion 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.

Countries

Italy

Contacts

CONTACTAntonia Carla Testa
antoniacarla.testa@policlinicogemelli.it+390630156399
PRINCIPAL_INVESTIGATORAntonia Carla Testa

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026