Ovarian Morphology in Girls

NCT04424576 | Recruiting

• 1 other identifier: IRB# 0000779
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Amenorrhea; Oligomenorrhea; Puberty

Keywords

Ovary; Transabdominal Ultrasound; Menarche; Periods; Microbiome

Outcome Measures

Primary Outcomes (3)

• Ovarian size

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

  24 months

• 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

• 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 Outcomes (5)

• Body composition

  24 months

• Leutenizing hormone (LH), follicle stimulating hormone (FSH), estradiol, progesterone, anti-mullerian hormone, free and total testosterone, and androstenedione

  24 months

• Sleep quality

  24 months

• Dietary composition

  24 months

• Gut microbiome richness and diversity

  24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 9 Years - 17 Years
• Gender Eligibility Details: Eligibility is limited to biologically female individuals because the primary study endpoints include the ovary and menstrual cycle.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cornell University: lead
• Children's Mercy Hospital Kansas City: collaborator

Study Sites (3)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

COMPLETED

Cornell University - Human Metabolic Research Unit

Ithaca, New York, 14853, United States

COMPLETED

University of Rochester, Strong Fertility Center

Rochester, New York, 14623, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine, Stool

MeSH Terms

Conditions

Amenorrhea; Oligomenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Kathleen Hoeger, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bailey Smith, MS

CONTACT

218-308-0560; bmd82@cornell.edu

Marla E Lujan, PhD

CONTACT

607-255-3153; mel245@cornell.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 11, 2020
• Study Start: January 31, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (3)