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

January 15, 2024 updated by: University Hospital, Montpellier
Puberty and long-term ovarian function of patients with a ovarian prenatal cyst has not described to date.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cases
Prenatal diagnosis of ovarian cyst
Other: Hormonal analysis, pelvic US
Other: controls
No prenatal diagnosis of cyst
Other: Hormonal analysis, pelvic US

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Age of puberty
Time Frame: 1 day
Clinical data and clinical history
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicular reserve
Time Frame: 1 day
Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Nicolas KALFA, MD, PhD, Montpellier University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2014

Primary Completion (Estimated)

November 24, 2024

Study Completion (Estimated)

November 24, 2024

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimated)

June 26, 2015

Study Record Updates

Last Update Posted (Estimated)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 15, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9434
  • 2014-A01025-42 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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