Status:
RECRUITING
Ovarian Morphology in Girls
Lead Sponsor:
Cornell University
Collaborating Sponsors:
Children's Mercy Hospital Kansas City
Conditions:
Amenorrhea
Oligomenorrhea
Eligibility:
FEMALE
9-17 years
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04424576
Start Date
January 31 2020
End Date
March 31 2025
Last Update
August 12 2024
Active Locations (3)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
2
Cornell University - Human Metabolic Research Unit
Ithaca, New York, United States, 14853
3
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623