Ovarian Morphology in Girls

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Cornell University
Study ID
NCT04424576
Status
Recruiting
Apply to this trial

Conditions

  • Amenorrhea
  • Oligomenorrhea
  • Puberty

Eligibility Criteria

Sex
FEMALE
Age
9 Years - 17 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jan 31, 2020
Status verified
Aug 2024
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Regular Menstrual Cycles
    22 adolescents with regular menstrual cycles (i.e., once every 4-6 weeks) will be enrolled within 11 months of menarche.
  • Arm: 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.

Primary Outcome Measure

Ovarian size [ Time Frame: 24 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Mercy HospitalKansas CityMissouri64108-
Cornell University - Human Metabolic Research UnitIthacaNew York14853-
University of Rochester, Strong Fertility CenterRochesterNew York14623
Kathleen Hoeger, MD
[email protected]

Find similar trials in Kansas City, MO

By research site
Children's Mercy Hospital· Kansas City, MOCornell University - Human Metabolic Research Unit· Ithaca, NYUniversity of Rochester, Strong Fertility Center· Rochester, NY

Related Studies