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TerminatedNCT02482467KYSTOVUpdated May 16, 2025

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

An interventional study of Hormonal analysis, pelvic US in Ovarian Cyst, sponsored by University Hospital, Montpellier. Terminated at 1 site in France. Open to female participants aged 6 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Other

Why this study was terminated
No difference between groups after analysis
Phase
Not applicable
Study type
Interventional
Enrollment
105
Allocation
Non-randomized
Ages
6 Years to 24 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ovarian Cyst

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Keywords

  • ovarian cyst
  • prenatal diagnosis
  • puberty
03

Who can participate

Ages eligible
6 Years to 24 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
105 participants (actual)

Study arms

  • Other
    Cases

    Prenatal diagnosis of ovarian cyst

    Other: Hormonal analysis, pelvic US

  • Other
    controls

    No prenatal diagnosis of cyst

    Other: Hormonal analysis, pelvic US

Interventions

  • OtherHormonal analysis, pelvic US
05

What researchers measure

Primary outcomes

  1. Age of puberty

    Clinical data and clinical history

    Time frame: 1 day

Secondary outcomes

  1. Follicular reserve

    Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography

    Time frame: 1 day

06

Study locations

1 site
  • Hôpital Lapeyronie
    Montpellier cedex 5, 34295, France
07

Registry details

Key details

Study ID
NCT02482467
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Jun 26, 2015
Start date
Nov 24, 2014
Primary completion
Mar 29, 2021
Completion
May 7, 2025
Last update
May 16, 2025

Study contacts

Nicolas KALFA, MD, PhD
principal investigator · Montpellier University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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