Ovarian Morphology in Girls
Recruiting now
Conditions studied: Amenorrhea, Oligomenorrhea, Puberty
In brief
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.
Key facts
- Study ID
- NCT04424576
- Run by
- Cornell University
- People needed
- 60
- Starts
- 2020-01-31
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2024-08-12
Who can join
Age: 9 and older, up to 17. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- University of Rochester, Strong Fertility Center — Rochester, New York, United States (enrolling)
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Cornell University - Human Metabolic Research Unit — Ithaca, New York, United States
Full record on ClinicalTrials.gov
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