Evaluation of Child Desire in Young Women With Premature Ovarian Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition,
研究概览
简要总结
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder.
详细描述
Premature ovarian failure (POF) is a rare condition, affecting 1 in 10,000 women before age 20 and 1 in 1,000 women before age 30. The two main causes of POF are congenital and acquired.
Patients with POF who carry out the desire to have a child turn to medically assisted reproduction through oocyte donation or to adoption.
The main endpoint of this study is to compare the desire to have children among women with premature ovarian failure (POF) aged 18 to 26 years vs. controls of the same age (stratified by age) without major menstruation disorder. The primary endpoint is the percentage of women with POF reporting a desire to have a child (yes / no) vs. controls of the same age with normal gonadal function/ The answers will be collected on two online questionnaires.
The secondary endpoints are:
- Look for a difference in the desire for a child according to the age at the diagnosis of POF, the cause of POF, the intake of hormone replacement therapy and the age of the patients at the time of the study.
- Assess the sexual life of women in POF.
- Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression. He will be assessed by the Hospital Anxiety and Depression Questionnaire to help identify those with symptoms of anxiety or depression.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 26 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18 to 26
- •Diagnosed with POF according to the following criteria:
- •Absence of pubertal development or primary or secondary amenorrhea for more than 4 months Follicle Stimulating Hormone (FSH) rate> 40 mL U /L, on at least two separate samples taken at least one month apart Low estradiol level <40 pg / mL
- •POF of congenital (Turner syndrome or other genetic cause) or acquired (post-therapeutic) origin
- •Who consulted in the Adolescent and Young Adult Gynecology Unit at bicetre Hospital between 2014 and 2021
排除标准
- •Minor patient or over 26 years old
- •Inability to complete the questionnaire
- •Lack of social security coverage
- •Patient under state medical aid
- •Patient under guardianship or curators or under legal protection
- •POF not confirmed (for patients only)
- •Condition impacting fertility or having already been pregnant or pregnant at the time of the study (for controls)
结局指标
主要结局
Percentage of POI patients expressing a desire for a child (yes/no) compared to controls of the same age with no fertility compromising condition,
时间窗: 3 months
To compare the desire for children of patients with premature ovarian failure (POI) aged 18-26 years with controls of the same age group (inclusion stratified by age in 2-year strata) with no fertility compromising condition.
次要结局
- Assess the psychological state of women with POF-related infertility and help identify those with symptoms of anxiety or depression.(3 months)
- Assess the sexual life of women with POF(3 months)