- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04424576
Ovarian Morphology in Girls (OMG)
Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition
Study Overview
Status
Conditions
Detailed 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 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Heidi Vanden Brink, PhD
- Phone Number: 816-960-4186
- Email: hvandenbrink@cmh.edu
Study Contact Backup
- Name: Marla E Lujan, PhD
- Phone Number: 607-255-3153
- Email: mel245@cornell.edu
Study Locations
-
-
Missouri
-
Kansas City, Missouri, United States, 64108
- Recruiting
- Children's Mercy Hospital
-
Contact:
- Heidi Vanden Brink, PhD
- Phone Number: 816-960-4186
-
Principal Investigator:
- Tania Burgert, MD
-
Principal Investigator:
- Romina Barral, MD
-
-
New York
-
Ithaca, New York, United States, 14853
- Suspended
- Cornell University - Human Metabolic Research Unit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Regular Menstrual Cycles
22 adolescents with regular menstrual cycles (i.e., once every 4-6 weeks) will be enrolled within 11 months of menarche.
|
Irregular Menstrual Cycles
26 adolescents with irregular menstrual cycles (i.e., < 4 weeks or > 6 weeks between periods) will be enrolled within 11 months of menarche.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ovarian size
Time Frame: 24 months
|
Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.
|
24 months
|
Follicle counts
Time Frame: 24 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.
|
24 months
|
Menstrual cycle status
Time Frame: 24 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.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body composition
Time Frame: 24 months
|
Changes in percent body fat, obtained using a bioimpedence scale, will be assessed over the first 2y post-menarche and compared across cohorts.
|
24 months
|
Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione
Time Frame: 24 months
|
Serum levels of these reproductive hormones will be assessed over the first 2y post-menarche and compared across cohorts.
|
24 months
|
Sleep quality
Time Frame: 24 months
|
Sleep quality will be assessed using two questionnaires: the Morningness-Eveningness Scale for Children and the Children's Report of Sleep Patterns.
Sleep quality will be assessed over the first 2y post-menarche and compared across cohorts.
|
24 months
|
Dietary composition
Time Frame: 24 months
|
Dietary composition (i.e., macro and micronutrient totals, total energy intake) will be assessed using two 24-Hour Food Frequency Questionnaires administered at each gynecological time point.
|
24 months
|
Gut microbiome richness and diversity
Time Frame: 24 months
|
Gut microbiome richness and diversity will be assessed over the first 2y post-menarche and compared across cohorts.
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Romina Barral, MD MSCR FAPP, Children's Mercy Hospital Kansas City
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB# 0000779
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amenorrhea
-
Mayo ClinicEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingHypothalamic AmenorrheaUnited States
-
University of Colorado, Colorado SpringsRecruitingAmenorrhea SecondaryUnited States
-
University of California, DavisCompletedBreast Feeding | Milk Expression, Breast | Amenorrhea, PostpartumUnited States
-
Imperial College LondonUniversity College, LondonRecruiting
-
TherapeuticsMDTerminated
-
Solvay PharmaceuticalsCompletedSecondary AmenorrheaUnited States
-
Catholic University of the Sacred HeartUnknownHypothalamic AmenorrheaItaly
-
Massachusetts General HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedExercise-related AmenorrheaUnited States
-
University Hospital, LilleRecruitingChemotherapy-Induced AmenorrheaFrance
-
University Hospital, Clermont-FerrandUnknownPregnant Women From 20 Amenorrhea WeeksFrance