Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea

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. Identifier: NCT03155828
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : May 16, 2017
Last Update Posted : August 3, 2018
Information provided by (Responsible Party):
Kelly Pagidas, University of Louisville

Brief Summary:
The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome will improve the regularity of the women's menstrual cycles.

Condition or disease Intervention/treatment
Sleep Apnea, Obstructive Anovulation Polycystic Ovarian Syndrome Device: CPAP

Detailed Description:

Women seeking fertility treatment at the University of Louisville will be screened for polycystic ovarian syndrome (PCOS) based on history and then blood work if history suggests PCOS. After establishing a diagnosis of PCOS based on the National Institute of Health criteria, they will be screened for impaired glucose tolerance, Class III obesity, and obstructive sleep apnea [using the Epworth Sleepiness Scale (ESS) as the initial screen]. For those women that screen positive on the ESS, they will be referred to the University of Louisville Physicians Sleep Center for a formal sleep study. Only patients with PCOS, severe obstructive sleep apnea, impaired glucose tolerance, and Class III obesity will qualify for enrollment in the study. Once enrolled, patients will be encouraged to use continuous positive airway pressure (CPAP, standard of care for treatment of obstructive sleep apnea) for at least six months. During those six months, patients will be asked to track their menstrual cycles and whether they took progesterone to induce a withdrawal bleed during that time period. The use of ovulation predictor kits to help determine ovulation status will be encouraged, but not required for the study.

During initial evaluation, patients seeking fertility care having a clinical presentation concerning for PCOS have their blood drawn for evaluation of thyroid stimulating hormone, free and total testosterone, antimullerian hormone, and 2 hour glucose tolerance test. At the conclusion of six months of CPAP therapy, patients will be asked to repeat the above blood tests for comparison to baseline values.

Women can continue to attempt pregnancy during the study time period if they desire.

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Novel Method of Restoring Menstrual Cyclicity or Ovulatory Function in PCOS Patients: The Use of CPAP to Improve More Than Sleep Quality
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : August 1, 2018

Intervention Details:
  • Device: CPAP
    Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care.

Primary Outcome Measures :
  1. Menstrual Cyclicity [ Time Frame: 6 months ]
    Resumption of regular cycles as evaluated either by paper menstrual calendar or use of a menstrual cycle application on smart phone or tablet.

Secondary Outcome Measures :
  1. Ovulation [ Time Frame: 6 months ]
    Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women seeking fertility treatment at the University of Louisville Reproductive Endocrinology and Infertility Center who have diagnosed polycystic ovarian syndrome, glucose intolerance, obesity, and obstructive sleep apnea.

Inclusion Criteria:

  • Age 18-35
  • English speakers
  • Polycystic ovarian syndrome by NIH criteria
  • Abnormal 2 hour glucose tolerance test
  • Body mass index >/= 40 kg/m2
  • Severe obstructive sleep apnea diagnosed with either a home or in-house sleep study

Exclusion Criteria:

  • Age <18 or >35
  • Non English speakers
  • No diagnosis of PCOS
  • Normal glucose tolerance test
  • No diagnosis of obstructive sleep apnea
  • Body mass index < 40 kg/m2
  • Using any form of hormonal contraception

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 identifier (NCT number): NCT03155828

United States, Kentucky
University of Louisville Fertility Center
Louisville, Kentucky, United States, 40205
Sponsors and Collaborators
University of Louisville
Principal Investigator: Kelly Pagidas, MD University of Louisville

Responsible Party: Kelly Pagidas, Professor, Obstetrics and Gynecology and Women's Health, University of Louisville Identifier: NCT03155828     History of Changes
Other Study ID Numbers: 16.0388
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kelly Pagidas, University of Louisville:

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Polycystic Ovary Syndrome
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases