Clinical trial NCT03155828: Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea
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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Sleep Apnea, Obstructive
Anovulation
Polycystic Ovarian Syndrome
Keywords: PCOS, OSA, CPAP
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Menstrual Cyclicity
timeFrame: 6 months
Secondary outcomes:
measure: Ovulation
timeFrame: 6 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Fertility Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Kelly Pagidas, MD
role: PRINCIPAL_INVESTIGATOR
References: