Actively Recruiting
Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
Led by Cornell University · Updated on 2024-08-12
60
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Cornell University
Lead Sponsor
C
Children's Mercy Hospital Kansas City
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates how ovarian shape and structure change during adolescence and relates these changes to menstrual cycle patterns, aiming to better understand reproductive health development. The study focuses on girls aged 9 to 17 years shortly after their first menstrual period, exploring how ovarian features and lifestyle factors like diet and sleep may predict regular or irregular menstrual cycles over two years. Participants will be followed in a prospective cohort design with four visits scheduled between 6 and 25 months after menarche. At each visit, they will undergo 3D ultrasound imaging of the ovaries and uterus, blood tests, physical measurements, and assessments of puberty stage, acne, and hair growth. They will also provide urine and stool samples and complete questionnaires on diet, physical activity, and sleep, though some procedures vary by site. Throughout the study, participants keep menstrual and medication diaries to track cycle patterns and treatments. Researchers will monitor ovarian size, follicle counts, hormone levels, body composition, sleep quality, diet, and gut microbiome diversity. The total participation period spans about two years, with careful safety and health assessments integrated to understand adolescent reproductive development.
CONDITIONS
Brief Title
Ovarian Morphology in Girls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adolescents aged 9 to 17 years
- Had their first menstrual period (menarche) within 11 months before enrollment
- At the University of Rochester site only: family history of polycystic ovary syndrome (mother or aunt)
You will not qualify if you...
- Use of medications or supplements affecting reproductive or metabolic function within the past 2 months (e.g., contraceptives, metformin, steroids, anti-seizure drugs)
- Untreated or unstable medical or mental health conditions likely to affect reproductive or metabolic function
- Currently pregnant or breastfeeding
- History of ovarian surgery
- Significant acute or chronic illness that may interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 years post-menarche
Participants attend study visits at four time points post-menarche to undergo assessments including ultrasound, fasting blood samples, anthropometric measurements, Tanner stage, acne and hirsutism scoring, and questionnaires on diet, sleep, and physical activity. Participants also self-collect stool and urine samples where applicable and maintain menstrual cycle and medication diaries between visits.
4 visits (in-person) at 6-10 months, 11-13 months, 17-19 months, and 23-25 months post-menarche
Trial Site Locations
Total: 3 locations
1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Completed
2
Cornell University - Human Metabolic Research Unit
Ithaca, New York, United States, 14853
Completed
3
University of Rochester, Strong Fertility Center
Rochester, New York, United States, 14623
Actively Recruiting
Research Team
B
Bailey Smith, MS
M
Marla E Lujan, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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