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Lack of enrollment
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Menstrual Cyclicity | Resumption of regular cycles as evaluated either by paper menstrual calendar or use of a menstrual cycle application on smart phone or tablet. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ovulation | Resumption of ovulatory cycles as evaluated by positive ovulation predictor kits. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Pagidas, MD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Fertility Center | Louisville | Kentucky | 40205 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D000858 | Anovulation |
| D011085 | Polycystic Ovary Syndrome |
| C564247 | Microcephaly, Primary Autosomal Recessive, 6 |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |