Understanding ovarian development in adolescent girls
Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
This study looks at how the structure of ovaries and factors like diet affect the menstrual cycles of adolescent girls in the two years after they start their periods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 9 Years to 17 Years |
| Sex | Female |
| Sponsor | Cornell University Academic / other |
| Locations | 3 sites (Kansas City, Missouri and 2 other locations) |
| Trial ID | NCT04424576 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between ovarian morphology and menstrual cycle regularity in adolescent girls. By utilizing 3D transabdominal ultrasound imaging, the study will track changes in ovarian structure over time, specifically in the two years following menarche. Additionally, the research will explore how environmental factors, such as diet and gut microbiome, may influence reproductive development. A cohort of up to 60 female adolescents will participate in four study visits, where they will undergo dietary assessments, stool sample collection, and ultrasound imaging.
Who should consider this trial
Good fit: Ideal candidates for this study are female adolescents aged 9 to 17 who have experienced menarche within the last 11 months.
Not a fit: Patients who are currently pregnant, breastfeeding, or have a history of ovarian surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into early indicators of reproductive health and help identify adolescents at risk for conditions like polycystic ovary syndrome.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding reproductive health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Missouri and 2 other locations
- Children's Mercy Hospital — Kansas City, Missouri, United States (Completed)
- Cornell University - Human Metabolic Research Unit — Ithaca, New York, United States (Completed)
- University of Rochester, Strong Fertility Center — Rochester, New York, United States (Recruiting)
Study contacts
- Principal investigator: Marla E Lujan, PhD — Cornell University
- Study coordinator: Bailey Smith, MS
- Email: bmd82@cornell.edu
- Phone: 218-308-0560
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.