Ovarian Morphology in Girls Study

This observational study is looking at how the ovaries develop in adolescent girls after their first period (menarche). Researchers want to understand if the size and number of follicles (small sacs in the ovaries that hold eggs) can predict whether a girl will have regular or irregular periods later on. They are also exploring if diet or sleep habits affect these changes. This study aims to help identify conditions like polycystic ovary syndrome (PCOS) earlier. Girls aged 9 to 17 who have had their first period within the last 11 months can join. For those at the University of Rochester site, a family history of PCOS (mother or aunt) is also required. The study will measure ovarian size, follicle counts, and menstrual cycle status over 24 months.

Study design
This is an observational study involving up to 60 female adolescents. It is not a drug trial, but rather observes natural changes over time.
What's involved
You would attend four study visits over approximately 24 months. Before each visit, you would complete a 24-hour dietary recall and provide a stool sample, and fast overnight.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months, with primary measurements taken at the end of this period.

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NCT04424576

Ovarian Morphology in Girls

Recruiting
Not specifiedAges 9–17Observational
Cornell University
~60 participants
Updated 2024-08-12 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ovarian size
Measured over 24 months
+2 more outcomes measured
Amenorrhea
Oligomenorrhea
Puberty
3 sites across 2 states
New York2
Missouri1
  • Marla E Lujan, PhD · PRINCIPAL_INVESTIGATOR · Cornell University
  • Tania Burgert, MD · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
  • Romina Barral, MD MSCR FAPP · PRINCIPAL_INVESTIGATOR · Children's Mercy Hospital Kansas City
  • Kathleen Hoeger, MD · PRINCIPAL_INVESTIGATOR · University of Rochester

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Eligibility criteria

Inclusion

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

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
  • Ovarian size24 months

    Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.

  • Follicle counts24 months

    Follicle counts, expressed as follicle number per ovary (FNPO) and follicle number per cross-section (FNPS), will be assessed over the first 2y post-menarche and compared across cohorts. Numbers of large follicles (\>10 mm diameter) and small follicles (\<10 mm diameter) will also be compared across cohorts.

  • Menstrual cycle status24 months

    Menstrual cycle status (i.e., regular versus irregular menstrual cycles) will be assessed using menstrual cycle records maintained by participants over the course of the study. Changes in menstrual cycle status over the 2y post-menarche and relationships between menstrual cycle status and other physiological and lifestyle factors will be examined.