Ovarian Morphology in Girls
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 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.
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 perturbations and
 subsequent future disease risk. Therefore, the objectives of this study are to determine
 whether there are distinct aspects of ovarian morphology that predict the likelihood of
 regular menses or cycle irregularity at 2y post-menarche and to determine whether diet or
 lifestyle (such as quality of sleep) contribute to changes in the ovaries and period
 patterns.

 A group of up to 60 adolescents will be enrolled into a prospective longitudinal cohort
 study. Participants will attend four study visits to their location's respective clinical
 research center. Study visits will occur at four distinct time points post-menarche: 6-10
 months, 11-13 months, 17-19 months, and 23-25 months.

 Prior to each of the study visits, participants will undergo one planned 24-hr dietary recall
 by a member of the research team and self-collect a stool sample. Participants will be asked
 to fast the night before the study visit. At each study visit, participants will undergo the
 following assessments:

 A 3D transabdominal ultrasound of the ovaries and uterus.

 A fasting blood sample, obtained via venipuncture.

 A series of anthropometric assessments, including: height, weight, waist and hip
 circumference, blood pressure, heart rate, and body fat percentage obtained using a
 bioimpedance scale.

 Tanner stage assessment, using a standardized self-report scoring scheme and by a trained
 member of the research team who is blinded to the results of the self-reported tanner stage.

 Acne scoring, using a standardized scoring scheme by a member of the research team.

 Hirsutism assessment, obtained by visually inspecting nine pre-defined regions of the body
 for terminal hair growth using a standardized scoring scheme by a trained member of the
 research team.

 Urine sample, self-collected by the participant after the transabdominal ultrasound.

 24-hour dietary recall.

 Physical activity questionnaire.

 Two sleep questionnaires, including questions about sleep hygiene, sleep quality, and
 circadian rhythms.

 In between study visits, participants will maintain menstrual cycle diaries and medication
 diaries.
Inclusion Criteria:

 -  Female adolescents aged 9 to 17 years

 -  Menarche within 11 months of the enrollment visit

 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