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

Nutritional and Metabolic Correlates of Ovarian Morphology in Women With 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: NCT01927471
Recruitment Status : Suspended (Suspended due to COVID-19; no suspension of IRB approval.)
First Posted : August 22, 2013
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 metabolism and age influence ovarian function. The purpose of the study is to understand how nutrition and metabolism relate to follicle development in women with regular cycles, irregular cycles, or polycystic ovary syndrome (PCOS). We also plan to identify lifestyle factors associated with PCOS and understand how diet and activity levels impact features of PCOS.

Condition or disease
Polycystic Ovary Syndrome (PCOS) Menstrual Irregularity

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Nutritional and Metabolic Correlates of Ovarian Morphology in Women With Polycystic Ovary Syndrome
Study Start Date : September 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Regular menstrual cycles
Adult women will be assigned to this category if they report a history of regular menstrual cycles. We will aim to recruit 120 women in this category.
Irregular menstrual cycles, no PCOS
Adult women will be assigned to this category if they report a history of irregular menstrual cycles, without a pre-existing diagnosis of PCOS. We will aim to recruit 120 women in this category.
Irregular menstrual cycles, with PCOS
Adult women will be assigned to this category if they report a history of irregular menstrual cycles with a pre-existing diagnosis of PCOS by a physician. We will aim to recruit 120 women in this category.



Primary Outcome Measures :
  1. Follicle number per ovary [ Time Frame: 1 day ]
    The number and size of all follicles in each ovary will be assess by ultrasonography for each participant with regular menstrual cycles, irregular menstrual cycles and PCOS.

  2. Insulin sensitivity [ Time Frame: 1 day ]
    Insulin sensitivity will be determined by administration of an oral glucose tolerance test and compared across groups.


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

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

  3. 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.

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

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

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

  7. Serum markers of metabolic syndrome [ Time Frame: 1 day ]
    Lipids, glucose and HbA1C concentrations will be determined and compared across groups.

  8. Blood Pressure [ Time Frame: 1 day ]
    Blood pressure will be determined and compared across groups.

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

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

  11. Body fat distribution [ Time Frame: 1 day ]
    Percentage and distribution of fat and lean mass as assessed using DXA technology will be compared across groups.

  12. Differences in diet composition between women with and without PCOS [ Time Frame: 1 week ]
    A food frequency questionnaire will be administered to assess diet composition for the last three months

  13. Differences in energy expenditure between women with and without PCOS [ Time Frame: 1 week ]
    Participants will be asked to wear a small accelerometer device to assess physical activity

  14. Subcutaneous fat biopsy (optional) [ Time Frame: 1 day ]
    Subcutaneous fat biopsies will be conducted to assess differences in fat cell populations (major site of reproductive hormone synthesis) between groups


Biospecimen Retention:   None Retained
Blood serum, subcutaneous fat


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 to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women must be able to transport to Cornell University and University of Rochester. Eligible participants are between 18-48 years with a BMI of 18 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:

  • Between 18 and 48 years
  • BMI ≥ 18 kg/m2

Either:

  • Regular menstrual cycles (21-35 days);
  • Irregular menstrual cycles (>36 days); or
  • Previous diagnosis of PCOS from a primary care provider
  • If 21 years of age or older, must have had a healthy pelvic exam w/in the past 2 years

Exclusion Criteria:

  • Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity
  • Pregnant or breastfeeding
  • Not otherwise healthy
  • Significant weight changes within the last three months

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): NCT01927471


Locations
Layout table for location information
United States, New York
Human Metabolic Research Unit, Cornell University
Ithaca, New York, United States, 14853
Strong Fertility Center
Rochester, New York, United States, 14623
CRC at University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
Cornell University
University of Rochester
Investigators
Layout table for investigator information
Principal Investigator: Marla E. Lujan, PhD Cornell University
Layout table for additonal information
Responsible Party: Cornell University
ClinicalTrials.gov Identifier: NCT01927471    
Other Study ID Numbers: IRB #: 1108002383
First Posted: August 22, 2013    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Keywords provided by Cornell University:
Menstrual cycles
Ultrasound
Ovary
Polycystic Ovary Syndrome (PCOS)
Physical activity
Diet
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Syndrome
Menstruation Disturbances
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases