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Ovarian Morphology in Girls

NCT04424576 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-08-12

No results posted yet for this study

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.

Conditions

  • Amenorrhea
  • Oligomenorrhea
  • Puberty

Sponsors & Collaborators

Principal Investigators

  • Marla E Lujan, PhD · Cornell University

  • Tania Burgert, MD · Children's Mercy Hospital Kansas City

  • Romina Barral, MD MSCR FAPP · Children's Mercy Hospital Kansas City

  • Kathleen Hoeger, MD · University of Rochester

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-31
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424576 on ClinicalTrials.gov