Insulin Sensitizers Role in Control of PCOS Vicious Cycle. (NCT06170463) | Clinical Trial Compass
CompletedPhase 1
Insulin Sensitizers Role in Control of PCOS Vicious Cycle.
Egypt210 participantsStarted 2022-08-01
Plain-language summary
PCOS is a common and complex disease affecting women of reproductive age. It is characterized by its complex pathological symptoms and mechanisms resulting in endocrine and metabolic dysfunction. PCOS is highly associated with various metabolic and endocrinal disorders. Metformin is mainly used for its glucose-lowering effects for treatment and prevention of type-2 diabetes mellitus (DM), gestational DM, and PCOS. Myo-inositol (MI) protects against MAFLD through reduction of hepatic accumulation of triglycerides.
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:
* Age;
* Residence;
* level of education \& type of work;
* Marital and fertility statuses, and if infertility was the main complaint;
* Presence of risk factors as sedentary lifestyle;
* Emotional stress and family history of PCOS;
* Obesity-related medical disorders especially DM or MAFLD;
* History of previous treatment for PCOS and its outcomes;
* Menstrual pattern such as infrequent menstrual periods.
Exclusion Criteria:
* Women had other manifestations of metabolic syndrome:
* Cardiac manifestations of PCOS;
* Maintained on other therapies or prepared for /received laparoscopic intervention for PCOS;
* Receiving scheduled exercise, lipid-lowering therapies, or maintained on diabetogenic drugs for any other indications;
* Had morbid obesity with body mass index (BMI) \>35 kg/m2;
* Causes other than PCOS for infertility, manifest DM, hepatic or pancreatic diseases.
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.