Back to resultsLetrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Primary Purpose
Infertility, Female
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
letrozole plus metformin
letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female
Eligibility 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.
Sites / Locations
- Assiut Faculty of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
letrozole plus metformin
letrozole
Arm Description
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
5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding
Outcomes
Primary Outcome Measures
The ovulation rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03135301
Brief Title
Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Official Title
Efficacy of Combined Letrozole-metformin in Comparison With Letrozole Only in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
letrozole plus metformin
Arm Type
Experimental
Arm Description
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
Arm Title
letrozole
Arm Type
Active Comparator
Arm Description
5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding
Intervention Type
Drug
Intervention Name(s)
letrozole plus metformin
Intervention Description
letrozole 5 milligram tablets plus metformin 850 milligram tablets
Intervention Type
Drug
Intervention Name(s)
letrozole
Intervention Description
letrozole 5 milligram tablets
Primary Outcome Measure Information:
Title
The ovulation rate
Time Frame
14 days
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Assiut Faculty of Medicine
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Abbas, MD
Phone
0100
Email
bmr90@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
36165742
Citation
Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Results Reference
derived
Learn more about this trial
Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
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