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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02442999
Other study ID # Pro00020545
Secondary ID
Status Terminated
Phase N/A
First received April 13, 2015
Last updated May 1, 2017
Start date January 2016
Est. completion date May 2017

Study information

Verified date May 2017
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.


Description:

The investigators' goal is to perform a randomized clinical trial among women with PCOS who present for infertility treatment. Our primary outcome is to determine if screening women with PCOS, and treating those with confirmed sleep apnea, will lead to more ovulatory cycles. Our sub-aims are to describe the rate of OSA and sleep symptoms in patients with PCOS, to see if current sleep questionnaires correlate to a diagnostic sleep study, to describe the correlation between OSA and biomarkers of glucose homeostasis in women with PCOS, to investigate health related quality of life between the groups, to compare perinatal outcomes between the groups, and to evaluate the composition of breastmilk among women who choose to breastfeed.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria

- Females 18 - 50 years old.

- Receiving care from an Obstetrician / gynecologist or a Reproductive endocrinology infertility specialist

- Polycystic ovarian syndrome defined by the modified Rotterdam criteria

- Able to speak and understand as well as give informed consent in English

Exclusion Criteria

- Late onset congenital adrenal hyperplasia

- Cushings disease

- Androgen-secreting tumors

- Previous diagnosis of obstructive sleep apnea

- Current use of over the counter or prescribed sleep medications.

- Examples of medications that exclude a patient from this study include but are not limited to Unisom, Ambien or Lunesta.

- Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these include but are not limited to melatonin, chamomile, or valerian.

- Untreated thyroid disease

- Prolactin excess

- Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Screening for obstructive sleep apnea

Device:
CPAP - continuous positive airway pressure


Locations

Country Name City State
United States USF REI Lakeland Lakeland Florida
United States USF REI St. Petersburg Saint Petersburg Florida
United States USF REI Sarasota Sarasota Florida
United States USF Morsani Tampa Florida
United States USF South Tampa Center Tampa Florida
United States USF REI Wesley Chapel Wesley Chapel Florida

Sponsors (1)

Lead Sponsor Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ovulatory cycles 3 months
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