Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Ovarian size
研究概览
简要总结
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive disturbances such as polycystic ovary syndrome (PCOS). The purpose of this research study is to determine whether the ovary can serve as a reliable predictor of normal or abnormal development by following the trajectory of ovarian morphology in conjunction with menstrual cyclicity using 3D transabdominal ultrasound imaging in a prospective cohort study of adolescents. A secondary objective is to identify potential environmental factors such as diet and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.
详细描述
Establishment of regular menstrual cycles is a key component of reproductive maturation and a recognized vital sign for health and well-being. Irregular menstrual cycles are especially common for the first 2-3 years after an adolescent's first menstrual period (i.e., menarche), which delays the identification and diagnosis of early reproductive perturbations and subsequent future disease risk. Therefore, the objectives of this study are to determine whether there are distinct aspects of ovarian morphology that predict the likelihood of regular menses or cycle irregularity at 2y post-menarche and to determine whether diet or lifestyle (such as quality of sleep) contribute to changes in the ovaries and period patterns.
A group of up to 60 adolescents will be enrolled into a prospective longitudinal cohort study. Participants will attend four study visits to their location's respective clinical research center. Study visits will occur at four distinct time points post-menarche: 6-10 months, 11-13 months, 17-19 months, and 23-25 months.
Prior to each of the study visits, participants will undergo one planned 24-hr dietary recall by a member of the research team and self-collect a stool sample.* Participants will be asked to fast the night before the study visit. At each study visit, participants will undergo the following assessments:
A 3D transabdominal ultrasound of the ovaries and uterus.
A fasting blood sample, obtained via venipuncture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female adolescents aged 9 to 17 years
- •Menarche within 11 months of the enrollment visit
- •University of Rochester site only: Family history of PCOS (i.e., mother or aunt)
排除标准
- •Current or recent use of medications or supplements known or suspected to interfere with reproductive or metabolic function in the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure medications)
- •Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function
- •Currently pregnant or breast feeding
- •History of ovarian surgery
- •Presence of significant acute or chronic illness which may interfere with study participation
结局指标
主要结局
Ovarian size
时间窗: 24 months
Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.
Follicle counts
时间窗: 24 months
Follicle counts, expressed as follicle number per ovary (FNPO) and follicle number per cross-section (FNPS), will be assessed over the first 2y post-menarche and compared across cohorts. Numbers of large follicles (\>10 mm diameter) and small follicles (\<10 mm diameter) will also be compared across cohorts.
Menstrual cycle status
时间窗: 24 months
Menstrual cycle status (i.e., regular versus irregular menstrual cycles) will be assessed using menstrual cycle records maintained by participants over the course of the study. Changes in menstrual cycle status over the 2y post-menarche and relationships between menstrual cycle status and other physiological and lifestyle factors will be examined.
次要结局
- Gut microbiome richness and diversity(24 months)
- Body composition(24 months)
- Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione(24 months)
- Sleep quality(24 months)
- Dietary composition(24 months)