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临床试验/NCT04526392
NCT04526392Unknown不适用

Pubertal Evolutionary Profile of Children Monitored for Fetal Ovarian Cyst

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2020年4月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
83
试验地点
1
主要终点
Age of onset of first menstruation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Age of onset of first menstruation

时间窗: Day 1

Age of onset of first menstruation defined with one decimal place (year and month).

次要结局

  • Hormonal levels - AMH(Day 1)
  • Hormonal levels - LH(Day 1)
  • Hormonal levels - FSH(Day 1)
  • Hormonal levels - estradiol(Day 1)
  • rate of ovarian cyst recurrence(Day 1)
  • Average age of maternal and sister rules(Day 1)
  • Presence or not of follicles(Day 1)
  • Ovarian volumes(Day 1)
  • first menstruation description - cycle disorder(Day 1)
  • first menstruation description - age of breast onset(Day 1)
  • first menstruation description dysmenorrhoea.(Day 1)
  • first menstruation description - cycle length(Day 1)
  • first menstruation description menorrhagia(Day 1)
  • percentage of hyperandrogenism(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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