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

NCT ID: NCT02482467

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-24

Study Completion Date

2025-05-07

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Cyst

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cases

Prenatal diagnosis of ovarian cyst

Group Type OTHER

Hormonal analysis, pelvic US

Intervention Type OTHER

controls

No prenatal diagnosis of cyst

Group Type OTHER

Hormonal analysis, pelvic US

Intervention Type OTHER

Interventions

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Hormonal analysis, pelvic US

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

24 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicolas KALFA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Montpellier University Hospital

Locations

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Hôpital Lapeyronie

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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2014-A01025-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

9434

Identifier Type: -

Identifier Source: org_study_id

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