Fetal Ovarian Cysts and IOTA Terminology for Perinatal Management

NCT07587580 | Not Yet Recruiting

• 1 other identifier: 27206
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Ovarian Cyst; Neonatal Ovarian Cyst

Outcome Measures

Primary Outcomes (1)

• Complication Rate in Conservatively Managed Fetal Ovarian Cysts

  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.

  From enrollment through 2 weeks postnatal follow-up

Study Arms (3)

Conservative Management

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.

Aspiration Management

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.

Surgical Management

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Pregnant women aged ≥18 years Singleton or multiple pregnancies with fetal ovarian cyst diagnosed by prenatal ultrasound at any gestational age Signed informed consent

You may not qualify if:

• Refusal to provide informed consent

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Neonatal ovarian cyst

Study Officials

• Antonia Carla Testa

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Carla Testa

CONTACT

+390630156399; antoniacarla.testa@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

IT (1)