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临床试验/NCT03155828
NCT03155828撤回不适用

A Novel Method of Restoring Menstrual Cyclicity or Ovulatory Function in PCOS Patients: The Use of CPAP to Improve More Than Sleep Quality

University of Louisville1 个研究点 分布在 1 个国家开始时间: 2016年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Menstrual Cyclicity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Menstrual Cyclicity

时间窗: 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.

次要结局

  • Ovulation(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kelly Pagidas

Professor, Obstetrics and Gynecology and Women's Health

University of Louisville

研究点 (1)

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