Health TrialsbyHealthPanel

Ovarian Morphology in Girls

ConditionsAmenorrheaOligomenorrheaPuberty
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age9-17
SponsorCornell University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Female adolescents aged 9 to 17 years

Menarche within 11 months of the enrollment visit

University of Rochester site only: Family history of PCOS (i.e., mother or aunt)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Regular Menstrual Cycles
Group B: Irregular Menstrual Cycles

Trial outcomes

Primary outcomes

1

Ovarian size

Changes in ovarian size over the first 2y post-menarche will be assessed and compared across cohorts.

Time frame
24 months
2

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.

Time frame
24 months
3

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.

Time frame
24 months

Secondary outcomes

1

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.

Time frame
24 months
2

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.

Time frame
24 months
3

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.

Time frame
24 months
4

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.

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cornell University

Lead sponsor

Children's Mercy Hospital Kansas City

Collaborator

Source ClinicalTrials.gov
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