NCT02482467

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
Last Updated

May 16, 2025

Status Verified

May 1, 2025

Enrollment Period

6.3 years

First QC Date

June 15, 2015

Last Update Submit

May 13, 2025

Conditions

Ovarian Cyst

Keywords

ovarian cystprenatal diagnosispuberty

Outcome Measures

Primary Outcomes (1)

  • Age of puberty

    Clinical data and clinical history

    1 day

Secondary Outcomes (1)

  • Follicular reserve

    1 day

Study Arms (2)

Cases

OTHER

Prenatal diagnosis of ovarian cyst

Other: Hormonal analysis, pelvic US

controls

OTHER

No prenatal diagnosis of cyst

Other: Hormonal analysis, pelvic US

Interventions

Hormonal analysis, pelvic USOTHER
Casescontrols

Eligibility Criteria

Age6 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Lapeyronie

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Ovarian Cysts

Condition Hierarchy (Ancestors)

CystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • Nicolas KALFA, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 26, 2015

Study Start

November 24, 2014

Primary Completion

March 29, 2021

Study Completion

May 7, 2025

Last Updated

May 16, 2025

Record last verified: 2025-05

Locations

FR(1)