Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

Fetal Ovarian Cyst Clinical Trial

— KOF  

Official title:

Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04526392
• Other study ID #: RC31/19/0497
• Status: Recruiting
• Start date: April 6, 2020
• Est. completion date: July 30, 2023

Study information

• Verified date: August 2020
• Source: University Hospital, Toulouse
• Contact: Catherine PIENKOWSKI, MD
• Phone: 5 34 55 85 53
• Email: pienkowski.c[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 83
• Est. completion date: July 30, 2023
• Est. primary completion date: April 15, 2023
• Gender: Female
• Age group: 8 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cysts
• Fetal Ovarian Cyst
• Ovarian Cysts

Intervention

Other:
• Questionnaire
Pubertal course questionnaire

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

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