Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 9
Maximum Age: 17
Healthy Volunteers: t
View:

• 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)

Locations
United States
Missouri
Children's Mercy Hospital
COMPLETED
Kansas City
New York
Cornell University - Human Metabolic Research Unit
COMPLETED
Ithaca
University of Rochester, Strong Fertility Center
RECRUITING
Rochester
Contact Information
Primary
Bailey Smith, MS
bmd82@cornell.edu
218-308-0560
Backup
Marla E Lujan, PhD
mel245@cornell.edu
607-255-3153
Time Frame
Start Date: 2020-01-31
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 60
Treatments
Regular Menstrual Cycles
22 adolescents with regular menstrual cycles (i.e., once every 4-6 weeks) will be enrolled within 11 months of menarche.
Irregular Menstrual Cycles
26 adolescents with irregular menstrual cycles (i.e., \< 4 weeks or \> 6 weeks between periods) will be enrolled within 11 months of menarche.
Related Therapeutic Areas
Sponsors
Collaborators: Children's Mercy Hospital Kansas City
Leads: Cornell University

This content was sourced from clinicaltrials.gov