Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Amenorrhea
  • Oligomenorrhea
  • Puberty
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 9 years and 17 years
Gender
Only males

Description

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...

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.

Tracking Information

NCT #
NCT04424576
Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Marla E Lujan, PhD Cornell University Principal Investigator: Tania Burgert, MD Children's Mercy Hospital Kansas City Principal Investigator: Romina Barral, MD MSCR FAPP Children's Mercy Hospital Kansas City