Ovarian Morphology in Girls

Amenorrhea Clinical Trial

— OMG  

Official title:

Trajectory of Ovarian Morphology During the Adolescent Reproductive Transition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04424576
• Other study ID #: IRB# 0000779
• Status: Recruiting
• Start date: January 31, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2022
• Source: Cornell University
• Contact: Heidi Vanden Brink, PhD
• Phone: 816-960-4186
• Email: hvandenbrink[@]cmh.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Amenorrhea
• Oligomenorrhea
• Puberty

Locations

Country	Name	City	State
United States	Cornell University - Human Metabolic Research Unit	Ithaca	New York
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Cornell University	Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovarian size	Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.	24 months
Primary	Follicle counts	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
Primary	Menstrual cycle status	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	Body composition	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
Secondary	Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione	Serum levels of these reproductive hormones will be assessed over the first 2y post-menarche and compared across cohorts.	24 months
Secondary	Sleep quality	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
Secondary	Dietary composition	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
Secondary	Gut microbiome richness and diversity	Gut microbiome richness and diversity will be assessed over the first 2y post-menarche and compared across cohorts.	24 months