RECRUITING

Ovarian Morphology in Girls

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition

Quick Facts

Study Start:2020-01-31
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04424576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 17 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Female adolescents aged 9 to 17 years
  2. * Menarche within 11 months of the enrollment visit
  3. * University of Rochester site only: Family history of PCOS (i.e., mother or aunt)
  1. * 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)
  2. * Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function
  3. * Currently pregnant or breast feeding
  4. * History of ovarian surgery
  5. * Presence of significant acute or chronic illness which may interfere with study participation

Contacts and Locations

Study Contact

Bailey Smith, MS
CONTACT
218-308-0560
bmd82@cornell.edu
Marla E Lujan, PhD
CONTACT
607-255-3153
mel245@cornell.edu

Principal Investigator

Marla E Lujan, PhD
PRINCIPAL_INVESTIGATOR
Cornell University
Tania Burgert, MD
PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Romina Barral, MD MSCR FAPP
PRINCIPAL_INVESTIGATOR
Children's Mercy Hospital Kansas City
Kathleen Hoeger, MD
PRINCIPAL_INVESTIGATOR
University of Rochester

Study Locations (Sites)

Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Cornell University - Human Metabolic Research Unit
Ithaca, New York, 14853
United States
University of Rochester, Strong Fertility Center
Rochester, New York, 14623
United States

Collaborators and Investigators

Sponsor: Cornell University

  • Marla E Lujan, PhD, PRINCIPAL_INVESTIGATOR, Cornell University
  • Tania Burgert, MD, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City
  • Romina Barral, MD MSCR FAPP, PRINCIPAL_INVESTIGATOR, Children's Mercy Hospital Kansas City
  • Kathleen Hoeger, MD, PRINCIPAL_INVESTIGATOR, University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-31
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2020-01-31
Study Completion Date2025-03-31

Terms related to this study

Keywords Provided by Researchers

  • Ovary
  • Transabdominal Ultrasound
  • Menarche
  • Periods
  • Microbiome

Additional Relevant MeSH Terms

  • Amenorrhea
  • Oligomenorrhea
  • Puberty