Ovarian Morphology in Girls
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 diagn
| Condition(s) | Amenorrhea, Oligomenorrhea, Puberty |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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) Exclusion Criteria: * 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 |
| Ages | 9 Years to 17 Years |
| Sex | Female |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Cornell University |
| Locations | Kansas City, Missouri, United States; Ithaca, New York, United States; Rochester, New York, United States |
| Start date | 2020-01-31 |
| NCT ID | NCT04424576 |
| Official listing | https://clinicaltrials.gov/study/NCT04424576 |