Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst

Not Applicable

Terminated

• Conditions: Ovarian Cyst
• Interventions: Other: Hormonal analysis, pelvic US

• Registration Number: NCT02482467
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

Detailed Description

The prenatal diagnosis of ovarian cysts is a common disease with an estimated incidence of 1 case per 2500 births. This pathology is the first diagnosis of abdominal cystic picture on the female fetus in the third trimester of pregnancy.Various complications of ovarian cysts have been described, such as ovarian torsion, breaking the cyst, hemorrhage intra cystic and compression of adjacent viscera. A conservative attitude for uncomplicated cysts is proposed in the literature but surgical care and / or puncture can be made to prevent the occurrence of complications and thus to protect ovarian tissue.However, no data on puberty and long-term ovarian prognosis in this disease is published in the literature. Without this information, no support for the recommendation of a prenatal ovarian cyst can be established formally.

Study Timeline

• Study Start: 2014-11-24
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-26
• Primary Completion: 2021-03-29
• Status Verified: 2025-05
• Study Completion: 2025-05-07
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• Collection of the written consent by the patients or the parents
• Membership in a health insurance scheme
• Group 1 : girl with prenatal ovarian cyst group 2: girl without prenatal ovarian cyst

Exclusion Criteria

• Refusal of participation of the patient or one of the two parents
• Deprived of freedom
• Pregnancy and current feeding
• Prenatal, neonatal or infantile history of ovarian pathology (Group 2)
• Genital congenital deformation or malformation syndrome gives a complex (group 2)
• Endocrine pathology except the juvenile disorders (group 2)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	Hormonal analysis, pelvic US	No prenatal diagnosis of cyst
Cases	Hormonal analysis, pelvic US	Prenatal diagnosis of ovarian cyst

Primary Outcome Measures

Name	Time	Method
Age of puberty	1 day	Clinical data and clinical history

Secondary Outcome Measures

Name	Time	Method
Follicular reserve	1 day	Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography

Trial Locations

Locations (1)

Hôpital Lapeyronie; 🇫🇷 Montpellier cedex 5, France