Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea
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|ClinicalTrials.gov Identifier: NCT03155828|
Recruitment Status : Enrolling by invitation
First Posted : May 16, 2017
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment|
|Sleep Apnea, Obstructive Anovulation Polycystic Ovarian Syndrome||Device: CPAP|
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|
|Estimated Enrollment :||5 participants|
|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|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
- Device: CPAP
Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care.
- 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.
- Ovulation [ Time Frame: 6 months ]Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits.
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): NCT03155828
|United States, Kentucky|
|University of Louisville Fertility Center|
|Louisville, Kentucky, United States, 40205|
|Principal Investigator:||Kelly Pagidas, MD||University of Louisville|