Ovarian Morphology in Girls

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age9-17
SponsorCornell University

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

60 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Cornell University

Lead sponsor

Children's Mercy Hospital Kansas City

Collaborator