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

Ovarian Cyst Clinical Trial

— KYSTOV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02482467
• Other study ID #: 9434
• Secondary ID: 2014-A01025-42
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2014
• Est. completion date: November 24, 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Nicolas KALFA, MD, PhD
• Phone: 04 67 33 87 82
• Email: n-kalfa[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: November 24, 2024
• Est. primary completion date: November 24, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 6 Years to 24 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cysts
• Ovarian Cyst
• Ovarian Cysts

Intervention

Other:
• Hormonal analysis, pelvic US

Locations

Country	Name	City	State
France	Hôpital Lapeyronie	Montpellier cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age of puberty	Clinical data and clinical history	1 day
Secondary	Follicular reserve	Serum level of Anti-Mullerian Hormone and ovarian volume at ultrasonography	1 day