Ovarian Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome

NCT03547453 | Completed

• 1 other identifier: 00070269
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators would like to determine how aspects of adiposity and age influence ultrasound features of the ovaries which are used to diagnose polycystic ovarian syndrome (PCOS). The study will also compare anti-Müllerian hormone (AMH) levels against ultrasound features of the ovary to predict PCOS.

Conditions

Polycystic Ovary Syndrome (PCOS); Menstrual Irregularity; Overweight and Obesity

Keywords

Menstrual cycles; Ultrasound; Ovary; Polycystic Ovary Syndrome (PCOS)

Outcome Measures

Primary Outcomes (1)

• Follicle number per ovary

  The number of follicles in each ovary will be assessed by ultrasonography

  1 day

Secondary Outcomes (12)

• Follicle number per cross section

  1 day

• Ovarian volume

  1 day

• Stromal echogenicity on ultrasound

  1 day

• Ovarian area-stromal area ratio

  1 day

• Follicle distribution pattern

  1 day

Study Arms (2)

Regular Menstrual Cycles

Women will be assigned to this category if they report a history of regular menstrual cycles (every 21 to 35 days). Recruitment will be targeted to obtain 20 lean (BMI\<25 kg/m2) and 20 overweight or obese (BMI\>24.9kg/m2) women in each of the following age groups: 18-24y (early), 25-34y (mid), ≥35y (later adulthood).

Polycystic Ovarian Syndrome

Women will be assigned to this category if they have clinical or biochemical androgen excess and report a history of irregular menstrual cycles (\<21 days or \>35 days), including women with a pre-existing diagnosis of PCOS. Recruitment will be targeted to obtain 20 lean (BMI\<25kg/m2) and 20 overweight or obese (BMI\>24.9kg/m2) women in each of the following age groups: 18-24y (early), 25-34y (mid), ≥35y (later adulthood).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women must be able to transport to the University of Rochester. Eligible participants are older than 18 years with a BMI of 18.5 kg/m2 or higher. Women are screened and enrolled following consent based on their response to our advertisements. Enrollment is restricted to the geographical area.

You may qualify if:

• Aged \>18 years
• At least 2y post-menarche
• BMI \>18.5kg/m2
• Good visibility of the ovaries on ultrasound
• Pelvic exam with normal results within the last 2 years
• Either:
• Regular menstrual cycles (21-35 days);
• Irregular menstrual cycles (\>36 days); or
• Previous diagnosis of PCOS from a primary care provider

You may not qualify if:

• Use of medication(s) known or suspected to interfere with reproductive function, metabolism, and/or appetite (e.g., oral contraceptives) within the past 3 months
• Use of fertility medications in the past 2 months (e.g., Clomid)
• Current use of a non-copper intrauterine device for contraception (e.g., Mirena)
• Diagnosis of premature ovarian failure, endometriosis, or another disease/disorder (other than PCOS) known or suspected to interfere with reproductive function
• History of ovarian surgery
• Missing uterus or an ovary
• Pregnant or breastfeeding
• Diagnosis of a bleeding disorder
• Regular use of blood thinners/anticoagulants
• Skin allergy/condition that might be aggravated by alcohol application
• Currently being treated for a vaginal infection, cervical infection, sexually transmitted infection, or disease either with antibiotics, antifungals, or anti-viral medication
• Abnormal vaginal discharge, pelvic pain, and/or blisters/lesions/warts/skin growths in the genital/anal area, which have not been examined by a medical professional.
• Vaginal abnormality (e.g., vaginal atresia/hypoplasia, vaginal septation, Mullerian agenesis, vulvar/vaginal malignancy).
• Not otherwise healthy

Sponsors & Collaborators

• Cornell University: lead
• University of Rochester: collaborator

Study Sites (1)

Strong Fertility Center

Rochester, New York, 14623, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples not containing DNA

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Menstruation Disturbances; Overweight; Obesity

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Study Officials

• Marla E. Lujan, PhD

  Cornell University

  PRINCIPAL INVESTIGATOR

• Kathleen Hoeger, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 6, 2018
• Study Start: June 4, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

US (1)