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Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

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ClinicalTrials.gov Identifier: NCT03135301
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

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
Infertility, Female Drug: letrozole plus metformin Drug: letrozole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : June 20, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : August 2018


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



Primary Outcome Measures :
  1. The ovulation rate [ Time Frame: 14 days ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135301


Locations
Egypt
Assiut Faculty of Medicine Recruiting
Assiut, Egypt
Contact: Ahmed Abbas, MD    0100    bmr90@hotmail.com   
Sponsors and Collaborators
Assiut University

Responsible Party: Ahmed Mohamed Abbas, Dr, Assiut University
ClinicalTrials.gov Identifier: NCT03135301     History of Changes
Other Study ID Numbers: LET
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

Additional relevant MeSH terms:
Infertility, Female
Infertility
Polycystic Ovary Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Letrozole
Clomiphene
Hypoglycemic Agents
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators