Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

Assiut University (Other)
Overall Status
CT.gov ID

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

Study Type:
Anticipated Enrollment :
80 participants
Intervention Model:
Parallel Assignment
None (Open Label)
Primary Purpose:
Official Title:
Efficacy of Combined Letrozole-metformin in Comparison With Letrozole Only in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome
Actual Study Start Date :
Jun 20, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

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

  1. The ovulation rate [14 days]

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:
  1. women with other causes of infertility as male factor,tubal factor,those with endocrine disorders as thyroid dysfunction and hyperprolactinemia.

  2. women who received hormonal treatment or ovulation induction drugs in the last 3 months before the study.

  3. women with history of liver,kidney or cardiovascular disease.

Contacts and Locations


Site City State Country Postal Code
1 Assiut Faculty of Medicine Assiut Egypt

Sponsors and Collaborators

  • Assiut University


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • LET
First Posted:
May 1, 2017
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022