Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome (NCT06405178) | Clinical Trial Compass
CompletedPhase 3
Adjuvant Therapy With Letrozole in Induction of Ovulation With Polycystic Ovarian Syndrome
Egypt200 participantsStarted 2026-03-30
Plain-language summary
The aim of the study is to assess the efficacy of adjuvant therapy dapagliflozin, metformin as monotherapy and combination of both in comparison to control group in induction of ovulation with letrozole in women PCOS, focusing specifically on rates of ovulation and pregnancy.
Who can participate
Age range
20 Years – 40 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:
* PCOS will based on European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine (ESHRE/ASRM) criteria, the diagnosis is made when at least two of the following criteria are met:
* oilgo and/or anovulation (infrequent or no ovulation),
* clinical and/or biochemical signs of hyperandrogenism including hirsutism, acne and/or increased testosterone levels
* polycystic ovaries on ultrasound (defined as those containing at least 12 follicles measuring 2-9 mm in diameter arranged peripherally around an echo-dense stroma and/or with increased ovarian volume of at least 10 ml).
Exclusion Criteria:
* Other causes of hyperandrogenism mimic PCOS such as congenital adrenal hyperplasia, Cushing's syndrome, or androgen secreting tumors are excluded.
* Persistent hyperprolactinemia,
* thyroid dysfunction defined as TSH \< 0.2 mIU/ML or \>5.5 mIU/mL)
* patients with menopausal levels of FSH (\> 15 mIU/mL) (A normal level within the last year is adequate for enter the study).
* Liver disease is defined as AST or ALT \> 2 times normal or total bilirubin \>2.5 mg/dL, #kidney disease defined as BUN \> 30 mg/dL or serum creatinine\> 1.4 mg/dL or significant
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
Pregnancy
Timeframe: 3 cycles ( 3 months / one month for each cycle)