Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst (KOF)

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.

Study Overview

• Status: Recruiting
• Conditions: Fetal Ovarian Cyst
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Anticipated): 83

Contacts and Locations

• Study Contact: Name: Catherine PIENKOWSKI, MD; Phone Number: +33 5 34 55 85 53; Email: pienkowski.c@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Toulouse University Hospital
    • Contact: Catherine PIENKOWSKI, MD; Phone Number: +33 5 34 55 85 53; Email: pienkowski.c@chu-toulouse.fr
    • Principal Investigator: Catherine PIENKOWSKI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Young girls who have to answer a questionnaire on their pubertal development. Estimated duration of data collection by questionnaire for one participant: 30 minutes maximum.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaire; Pubertal course questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of onset of first menstruation	Age of onset of first menstruation defined with one decimal place (year and month).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average age of maternal and sister rules	Average age of maternal and sister menstruation.	Day 1
Ovarian volumes	Homo and contralateral ovarian volumes at the cyst.	Day 1
Presence or not of follicles	Presence or not of follicles on both ovaries.	Day 1
first menstruation description - age of breast onset	Age of breast onset	Day 1
first menstruation description - cycle length	cycle length in the last three months	Day 1
first menstruation description - cycle disorder	rate of patients with cycle disorder	Day 1
first menstruation description dysmenorrhoea.	dysmenorrhoea.	Day 1
first menstruation description menorrhagia	menorrhagia	Day 1
percentage of hyperandrogenism	Percentage of girls with clinical signs of hyperandrogenism or elevated testosterone levels.	Day 1
Hormonal levels - AMH	AMH levels	Day 1
Hormonal levels - LH	Luteinizing hormone (LH) levels	Day 1
Hormonal levels - FSH	follicle stimulating hormone (FSH) levels	Day 1
Hormonal levels - estradiol	estradiol levels	Day 1
rate of ovarian cyst recurrence	Ovarian cyst recurrence rate	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Catherine PIENKOWSKI, MD, Toulouse University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: child; puberty
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Pathological Conditions, Anatomical; Ovarian Cysts; Cysts
• Other Study ID Numbers: RC31/19/0497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No