Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fetal Ovarian Cyst | — | UNRESOLVED | — |
| Neonatal Ovarian Cyst | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Conservative Management
- description
- Fetal ovarian cysts with unilocular anechoic or low-level cystic content measuring less than 4 cm at enrollment, managed conservatively with serial ultrasound follow-up every two weeks during pregnancy and after birth unless changes in morphology or increase in size occur.
- label
- Aspiration Management
- description
- Fetal ovarian cysts with unilocular anechoic or low-level cystic content measuring more than 4 cm, managed either by intrauterine aspiration or postnatal laparoscopic aspiration, with serial ultrasound follow-up every two weeks.
- label
- Surgical Management
- description
- Fetal ovarian cysts with ground-glass appearance, hemorrhagic content, mixed echogenicity, or other complex ultrasound features, monitored during pregnancy and surgically managed after birth according to clinical evaluation.
Primary outcomes (1)
- measure
- Complication Rate in Conservatively Managed Fetal Ovarian Cysts
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available