Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome (NCT02302326) | Clinical Trial Compass
CompletedNot Applicable
Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome
Spain50 participantsStarted 2013-01
Plain-language summary
The main objective of the present project is to evaluate the relevance of reticulum stress in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities. Furthermore, the investigators will assess the potential of insulin sensitizers as a treatment to control endoplasmic reticulum stress markers in PCOS patients.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women diagnosed with PCOS using the Rotterdam criteria
* Women of reproductive age
Exclusion Criteria:
* Organic, malignant, haematological, infectious or inflammatory disease
* History of ischaemic heart disease (stroke or thromboembolism)
* Diabetes mellitus,
* Secondary causes of obesity (hypothyroidism, Cushing's syndrome)
* Severe hypertension.
* Smoking or alcohol habit
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in markers of endoplasmic reticulum stress in controls and pcos women before and after metformin/Myo-inositol + folic acid administration
Timeframe: 3 months
2
Changes in markers of the insulin pathway in controls and pcos women before and after metformin/Myo-inositol + folic acid administration
Timeframe: 3 months
3
Changes in inflammatory parameters in controls and pcos women before and after metformin/Myo-inositol + folic acid administration
Timeframe: 3 months
4
Changes in apoptotic parameters in controls and pcos women before and after metformin/Myo-inositol + folic acid administration
Timeframe: 3 months
Trial details
NCT IDNCT02302326
SponsorFundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana