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

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Terminated

Conditions

Ovarian Cyst

Treatments

Other: Hormonal analysis, pelvic US

Study type

Interventional

Funder types

Other

Identifiers

NCT02482467
9434
2014-A01025-42 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

105 patients

Sex

Female

Ages

6 to 24 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

Cases
Other group
Description:
Prenatal diagnosis of ovarian cyst
Treatment:
Other: Hormonal analysis, pelvic US
controls
Other group
Description:
No prenatal diagnosis of cyst
Treatment:
Other: Hormonal analysis, pelvic US

Trial contacts and locations

1

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Central trial contact

Nicolas KALFA, MD, PhD

Data sourced from clinicaltrials.gov

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