Using ultrasound descriptions to guide care for ovarian cysts found before birth
Follows pregnant women whose babies have ovarian cysts, using a standard ultrasound classification.
Plain-language title generated from the registry record
Registry title: Fetal Ovarian Cysts and IOTA Terminology for Perinatal Management
Key facts
- Where
- Roma, ItalySee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for pregnant women aged 18 or older whose baby has an ovarian cyst seen on ultrasound. Women are followed during pregnancy and after birth.
- Age
- 18 years or older
- Sex
- Women (female)
- Disease stage
- Ovarian cyst in the fetus, found on prenatal ultrasound at any stage of pregnancy. Single or multiple pregnancies can join.
Main reasons for not taking part
- Refusal to give signed informed consent
This trial only enrols pregnant participants. The registry sentence this rests on: Pregnant women aged ≥18 years Singleton or multiple pregnancies with fetal ovarian cyst diagnosed by prenatal ultrasound at any gestational age Signed informed consent
Read by machine on 12 November 2026.
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyContact: ANTONIA CARLA TESTA, ProfessorNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07587580
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Fetal Ovarian Cysts: Application of the International Ovarian Tumor Analysis (IOTA) Terminology and Implications for Perinatal Management
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.
Inclusion: 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: Refusal to provide informed consent.