Actively Recruiting

Age: 9Years - 17Years
FEMALE
Healthy Volunteers
NCT04424576

Ovarian Morphology in Girls

Led by Cornell University · Updated on 2024-08-12

60

Participants Needed

3

Research Sites

269 weeks

Total Duration

On this page

Sponsors

C

Cornell University

Lead Sponsor

C

Children's Mercy Hospital Kansas City

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Ovarian Morphology in Girls

Who Can Participate

Age: 9Years - 17Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adolescents aged 9 to 17 years
  • Menarche within 11 months of the enrollment visit
  • University of Rochester site only: Family history of PCOS (mother or aunt)
Not Eligible

You will not qualify if you...

  • Use of medications or supplements affecting reproductive or metabolic function in past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure drugs)
  • Untreated or unstable medical or mental health condition affecting reproductive or metabolic function
  • Currently pregnant or breastfeeding
  • History of ovarian surgery
  • Significant acute or chronic illness that may interfere with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Completed

2

Cornell University - Human Metabolic Research Unit

Ithaca, New York, United States, 14853

Completed

3

University of Rochester, Strong Fertility Center

Rochester, New York, United States, 14623

Actively Recruiting

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Research Team

B

Bailey Smith, MS

CONTACT

M

Marla E Lujan, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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