RecruitingNCT04424576

Ovarian Morphology in Girls

Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition


Sponsor

Cornell University

Enrollment

60 participants

Start Date

Jan 31, 2020

Study Type

OBSERVATIONAL

Conditions

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 and the gut microbiome which influence the trajectory towards normal or abnormal reproductive development.


Eligibility

Sex: FEMALEMin Age: 9 YearsMax Age: 17 Years

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Locations(3)

Children's Mercy Hospital

Kansas City, Missouri, United States

Cornell University - Human Metabolic Research Unit

Ithaca, New York, United States

University of Rochester, Strong Fertility Center

Rochester, New York, United States

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NCT04424576


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