Recruiting

Observational Study

Sponsor:

Cornell University

Code:

NCT04424576

Conditions

Amenorrhea

Oligomenorrhea

Puberty

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Accepted

Study Details

Brief 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

Study ID

NCT04424576

Start date

Jan 31, 2020

Status verified date

Aug, 2024

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 9 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  • Untreated and/or unstable medical or mental health condition known or suspected to interfere with reproductive or metabolic function
  • Currently pregnant or breast feeding
  • History of ovarian surgery
  • Presence of significant acute or chronic illness which may interfere with study participation

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Ovarian size [ Time Frame: 24 months ]
  • Follicle counts [ Time Frame: 24 months ]
  • Menstrual cycle status [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Bailey Smith, MS

218-308-0560bmd82@cornell.edu

Marla E Lujan, PhD

607-255-3153mel245@cornell.edu

Locations

University of Rochester, Strong Fertility Center

Recruiting

Rochester, New York, United States, 14623

Contacts

Kathleen Hoeger, MD

kathy_hoeger@urmc.rochester.edu

More Information

Sponsor

Cornell University

Last update posted

Aug 12, 2024

Last verified

Aug, 2024

Keywords

  • Ovary
  • Transabdominal Ultrasound
  • Menarche
  • Periods
  • Microbiome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cornell University on 2024-08-12.