Status:
UNKNOWN
Pro-vascular Regenerative Cell Exhaustion in Women With Polycystic Ovarian Syndrome
Lead Sponsor:
Canadian Medical and Surgical Knowledge Translation Research Group
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
30+ years
Brief Summary
PCOS-RCE is an observational, cross-sectional, two-arm study that is aimed at determining if an established diagnosis of polycystic ovarian syndrome (PCOS) influences the number of blood vessel-formin...
Detailed Description
Individuals with polycystic ovarian syndrome (PCOS) have been reported to be at higher risk of cardiovascular disease when compared to those without PCOS. While differential environmental exposures an...
Eligibility Criteria
Inclusion
- Capable and willing to provide informed consent
- Females aged 30 and above
- Must meet criteria for one of the following two groups:
- Documented diagnosis of PCOS OR
- Normal and regular menstrual cycles with no known diagnosis of PCOS
Exclusion
- Menopause, as defined by 12 months of amenorrhea
- Known causes of irregular menstrual bleeding caused by conditions other than PCOS
- Known secondary causes of ovulatory dysfunction and/or hyperandrogenism
- Current pregnancy, active lactation, or less than 6 months postpartum
- Ongoing treatment with ovulation-inducing medication
- History of hysterectomy and/or bilateral oophorectomy
- Severe congestive heart failure (as defined by New York Heart Association - class IV)
- Any life-threatening disease expected to result in death within the next 2 years
- Any malignancy not considered cured. A subject is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening.
- Known severe liver disease
- Known acquired immunodeficiency syndrome such as HIV
- Current treatment with systemic or oral corticosteroid therapy or other immunosuppressive agents
- Known autoimmune disorder (exception: type 1 diabetes)
- Active infectious disease requiring antibiotic or anti-viral agents
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05410834
Start Date
June 1 2022
End Date
April 1 2023
Last Update
June 8 2022
Active Locations (3)
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1
Centrum Services Newmarket
Newmarket, Ontario, Canada, L3Y 2N1
2
Diagnostic Assessment Centre
Scarborough Village, Ontario, Canada, M1S 4N6
3
Langstaff Medical Centre
Woodbridge, Ontario, Canada, L4L 1A6