Actively Recruiting
Ovarian Morphology in Girls
Led by Cornell University · Updated on 2024-08-12
60
Participants Needed
3
Research Sites
269 weeks
Total Duration
On this page
Sponsors
C
Cornell University
Lead Sponsor
C
Children's Mercy Hospital Kansas City
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ovarian Morphology in Girls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adolescents aged 9 to 17 years
- Menarche within 11 months of the enrollment visit
- University of Rochester site only: Family history of PCOS (mother or aunt)
You will not qualify if you...
- Use of medications or supplements affecting reproductive or metabolic function in past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure drugs)
- Untreated or unstable medical or mental health condition affecting reproductive or metabolic function
- Currently pregnant or breastfeeding
- History of ovarian surgery
- Significant acute or chronic illness that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Completed
2
Cornell University - Human Metabolic Research Unit
Ithaca, New York, United States, 14853
Completed
3
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623
Actively Recruiting
Research Team
B
Bailey Smith, MS
CONTACT
M
Marla E Lujan, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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