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 Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome

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: NCT03547453
Recruitment Status : Suspended (Suspended due to COVID-19; no suspension of IRB approval.)
First Posted : June 6, 2018
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
University of Rochester
Information provided by (Responsible Party):
Cornell University

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.

Condition or disease
Polycystic Ovary Syndrome (PCOS) Menstrual Irregularity Overweight and Obesity

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Ovarian Ultrasonography for the Clinical Evaluation of Polycystic Ovary Syndrome
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. Follicle number per ovary [ Time Frame: 1 day ]
    The number of follicles in each ovary will be assessed by ultrasonography


Secondary Outcome Measures :
  1. Follicle number per cross section [ Time Frame: 1 day ]
    The number all follicles in a single cross sectional plane of each ovary will be assessed by ultrasonography

  2. Ovarian volume [ Time Frame: 1 day ]
    The size of each ovary will be determined by ultrasonography for each participant and compared across groups.

  3. Stromal echogenicity on ultrasound [ Time Frame: 1 day ]
    The brightness of the ovarian stroma in a single cross section will be determined by ultrasonography for each participant and compared across groups.

  4. Ovarian area-stromal area ratio [ Time Frame: 1 day ]
    The ratio of the stromal area to the total ovarian area of the ovary in a single cross section will be determined by ultrasonography for each participant and compared across groups.

  5. Follicle distribution pattern [ Time Frame: 1 day ]
    The follicle distribution pattern will be assessed by ultrasonography for each participant and compared across groups.

  6. Anti-Müllerian hormone [ Time Frame: 1 day ]
    Circulating AMH levels in the serum will be determined for each participant and compared across groups.

  7. LH-FSH ratio [ Time Frame: 1 day ]
    The ratio of circulating LH to FSH concentrations in the serum will be determined for each participant and compared across groups

  8. Hirsutism Score [ Time Frame: 1 day ]
    Degree of hirsutism as judged by the Ferriman-Gallwey scale will be determined and compared across groups

  9. Androgen concentrations [ Time Frame: 1 day ]
    Total testosterone, androstenedione and free androgen index concentrations in serum will be determined and compared across groups.

  10. Menstrual Cycle Length [ Time Frame: 1 day ]
    Average menstrual cycle length as determined by self-reported history will be determined and compared across groups

  11. Body mass index [ Time Frame: 1 day ]
    The ratio of weight to height will be determined and compared across groups.

  12. Waist-to-hip ratio [ Time Frame: 1 day ]
    The ratio of waist circumference to hip circumference will be determined and compared across groups.



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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): NCT03547453


Locations
Layout table for location information
United States, New York
Strong Fertility Center
Rochester, New York, United States, 14623
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Marla E. Lujan, PhD Cornell University
Principal Investigator: Kathleen Hoeger, MD University of Rochester
Layout table for additonal information
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT03547453    
Other Study ID Numbers: 00070269
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 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:
Menstrual cycles
Ultrasound
Ovary
Polycystic Ovary Syndrome (PCOS)
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Overweight
Menstruation Disturbances
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases