Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ovarian Morphology in Girls (OMG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Children's Mercy Hospital Kansas City
Information provided by (Responsible Party):
Cornell University

Brief Summary:
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.

Condition or disease
Amenorrhea Oligomenorrhea Puberty

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation

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.



Primary Outcome Measures :
  1. Ovarian size [ Time Frame: 24 months ]
    Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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
Blood, Urine, Stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is limited to biologically female individuals because the primary study endpoints include the ovary and menstrual cycle.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Female adolescents between the ages of 9 and 17 years who achieved menarche (i.e., very first period) within the past 11 months will be recruited.
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
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
Sponsors and Collaborators
Cornell University
Children's Mercy Hospital Kansas City
Investigators
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT04424576    
Other Study ID Numbers: IRB# 0000779
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cornell University:
Ovary
Transabdominal Ultrasound
Menarche
Periods
Microbiome
Additional relevant MeSH terms:
Layout table for MeSH terms
Amenorrhea
Oligomenorrhea
Menstruation Disturbances
Pathologic Processes