Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst (KYSTOV)
Primary Purpose
Ovarian Cyst
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hormonal analysis, pelvic US
Sponsored by
About this trial
This is an interventional other trial for Ovarian Cyst focused on measuring ovarian cyst, prenatal diagnosis, puberty
Eligibility Criteria
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)
Sites / Locations
- Hôpital LapeyronieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cases
controls
Arm Description
Prenatal diagnosis of ovarian cyst
No prenatal diagnosis of cyst
Outcomes
Primary Outcome Measures
Age of puberty
Clinical data and clinical history
Secondary Outcome Measures
Follicular reserve
Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography
Full Information
NCT ID
NCT02482467
First Posted
June 15, 2015
Last Updated
December 13, 2022
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02482467
Brief Title
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
Acronym
KYSTOV
Official Title
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2014 (Actual)
Primary Completion Date
November 24, 2024 (Anticipated)
Study Completion Date
November 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst
Keywords
ovarian cyst, prenatal diagnosis, puberty
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Other
Arm Description
Prenatal diagnosis of ovarian cyst
Arm Title
controls
Arm Type
Other
Arm Description
No prenatal diagnosis of cyst
Intervention Type
Other
Intervention Name(s)
Hormonal analysis, pelvic US
Primary Outcome Measure Information:
Title
Age of puberty
Description
Clinical data and clinical history
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Follicular reserve
Description
Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography
Time Frame
1 day
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas KALFA, MD, PhD
Phone
04 67 33 87 82
Ext
0033
Email
n-kalfa@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas KALFA, MD, PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Lapeyronie
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas KALFA, MD, PhD
Phone
04 67 33 87 82
Ext
0033
Email
n-kalfa@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Françoise PARIS, MD, PhD
Phone
04 67 33 83 28
Ext
0033
Email
f-paris@chu-montpellier.fr
12. IPD Sharing Statement
Learn more about this trial
Prognosis and Long Term Pubertal Outcome of Girls Previously Diagnosed With a Prenatal Ovarian Cyst
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