Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Study Details
Study Description
Brief Summary
Polycystic ovary syndrome accounts for the vast majority of anovulatory symptoms and hyperandrogenism in women. The diagnosis of Polycystic ovary syndrome has life-long implications, with increased risk for infertility, metabolic syndrome, and type 2 diabetes mellitus, and possibly for cardiovascular disease and endometrial carcinoma. Polycystic ovary syndrome is diagnosed in adolescents with otherwise unexplained, persistent hyperandrogenic anovulatory symptoms that are inappropriate for age and stage of adolescence. It should be considered in any adolescent girl with a chief complaint of hirsutism, treatment-resistant acne, menstrual irregularity, acanthosis nigricans, and/or obesity
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: letrozole plus metformin 5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding plus metformin will be started from the first day with a dose of 850 mg (1 tablet daily) and the dosage will be increased after 1 week up to 1,700 mg/day (2 tablets daily) and will be continued |
Drug: letrozole plus metformin
letrozole 5 milligram tablets plus metformin 850 milligram tablets
|
Active Comparator: letrozole 5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding |
Drug: letrozole
letrozole 5 milligram tablets
|
Outcome Measures
Primary Outcome Measures
- The ovulation rate [14 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
- polycystic ovaries patients who had failed to become pregnant after 3 courses of 150 mg of clomiphene citrate (considered as clomiphene resistant),whereas the value of the above mentioned investigation are normal.
Exclusion Criteria:
-
women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia.
-
women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study.
-
women with history of liver,kidney or cardiovascular disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Assiut Faculty of Medicine | Assiut | Egypt |
Sponsors and Collaborators
- Assiut University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LET