Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

NCT ID: NCT04526392

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-06
• Study Completion Date: 2023-07-30

Brief Summary

This study is based on pubertal surveillance of fetal ovarian cysts (KOF). Fetal ovarian cysts (KOF) detected during fetal ultrasound examinations occur during the 3rd trimester of pregnancy and are of unknown cause.

Detailed Description

These cysts are functional in the vast majority of cases and are therefore likely to disappear spontaneously, but they may become complicated before regressing. Apart from complication, the natural evolution of these cysts, which are said to be "simple" because they are liquid on ultrasound, is towards regression in the first months of neo-natal life.

Surveillance during the 1st year of life showed that simple cysts regressed during the 1st trimester. In the case of complicated cysts, oophorectomy was necessary in 9 cases. In the 1-year follow-up, the ovarian recovery rate was significantly different depending on the appearance of the cyst (p<0.0001); 60 ovaries out of 89 homolateral to the cyst were follicular, of which 48/49 (98%) were carriers of fluid cysts and 12/40 (30%) were initially heterogeneous. The origin of these cysts is unknown, the ovary is again physiologically stimulated during the onset of puberty. No series in the literature gives the long-term ovarian prognosis for these patients. We wish to evaluate the pubertal evolutionary profile of patients followed at the University Hospital for KOF. The data collected concerning puberty (age of menses) will be examined in relation to the age of menses in the siblings and in the mother, as well as to the data in the literature on the age of the first menses in France.

Conditions

Fetal Ovarian Cyst

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Questionnaire

Patients will choose how they wish to complete the Pubertal Course Questionnaire: electronically (web link), on paper, by telephone, or face-to-face at a follow-up consultation.

Questionnaire

Intervention Type: OTHER

Pubertal course questionnaire

Interventions

Questionnaire

Pubertal course questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients at least 8 years of age at the time of inclusion.
• Patients being followed for fetal ovarian cyst.
• Minor patients of whom at least one of the two holders of parental authority has given his or her non-opposition.
• Patients covered by a social security scheme.

Exclusion Criteria

• Patients less than 8 years of age at the time of inclusion
• Ovarian cysts outside the neonatal period
• Refusal to participate.
• Opposition to disclosure of neonatal data.
• Pregnant or nursing patient.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine PIENKOWSKI, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Toulouse University Hospital

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Catherine PIENKOWSKI, MD

Role: CONTACT

pienkowski.c@chu-toulouse.fr

5 34 55 85 53 ext. +33

Facility Contacts

Catherine PIENKOWSKI, MD

Role: primary

pienkowski.c@chu-toulouse.fr

5 34 55 85 53 ext. +33

Other Identifiers

RC31/19/0497

Identifier Type: -

Identifier Source: org_study_id