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Ovarian Morphology in Girls
NCT04424576 · View on ClinicalTrials.gov ↗
Study 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 Studied
Study Locations (3)
New York
- Cornell University - Human Metabolic Research Unit — Ithaca
- University of Rochester, Strong Fertility Center — Rochester
Missouri
- Children's Mercy Hospital — Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-01-31 |
| Est. Completion | 2025-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04424576
The ClinicalTrials.gov registry entry for NCT04424576 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cornell University, which has 50 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Puberty appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04424576 reports 3 study locations spanning 2 distinct geographic areas — top geographies include New York, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04424576 about?
NCT04424576 is a clinical study titled "Ovarian Morphology in Girls". 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 iden...
What is the current status of trial NCT04424576?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2020-01-31. Estimated completion is 2025-03-31.
What conditions does trial NCT04424576 study?
This clinical trial studies the following conditions: Puberty, Amenorrhea, Oligomenorrhea. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT04424576?
This trial is sponsored by Cornell University, which has 50 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04424576 being conducted?
This trial has 3 study locations across Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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