Ovarian Morphology in Girls (OMG)
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|ClinicalTrials.gov Identifier: NCT04424576|
Recruitment Status : Suspended (Suspended due to COVID-19. No suspension of IRB approval.)
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
|Condition or disease|
|Amenorrhea Oligomenorrhea Puberty|
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 :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition|
|Actual Study Start Date :||January 31, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
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.
- Ovarian size [ Time Frame: 24 months ]Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424576
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64108|
|United States, New York|
|Cornell University - Human Metabolic Research Unit|
|Ithaca, New York, United States, 14853|
|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|