| NCT ID | NCT04424576 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cornell University |
| Condition | Amenorrhea |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-01-31 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2020-01-31 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Marla E Lujan, PhD
PRINCIPAL INVESTIGATOR
Cornell University
Frequently Asked Questions
Who can join the NCT04424576 clinical trial?
This trial is open to female participants only, aged 9 Years or older, up to 17 Years, studying Amenorrhea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04424576 currently recruiting?
Yes, NCT04424576 is actively recruiting participants. Contact the research team at bmd82@cornell.edu for enrollment information.
Where is the NCT04424576 trial being conducted?
This trial is being conducted at Kansas City, United States, Ithaca, United States, Rochester, United States.
Who is sponsoring the NCT04424576 clinical trial?
NCT04424576 is sponsored by Cornell University. The principal investigator is Marla E Lujan, PhD at Cornell University. The trial plans to enroll 60 participants.