Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2024-03-31

Brief Summary

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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

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Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

letrozole plus metformin

Intervention Type DRUG

letrozole 5 milligram tablets plus metformin 850 milligram tablets

letrozole

5 mg of letrozole will be administered only for 5 days from day 3 each month of spontaneous or induced bleeding

Group Type ACTIVE_COMPARATOR

letrozole

Intervention Type DRUG

letrozole 5 milligram tablets

Interventions

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letrozole plus metformin

letrozole 5 milligram tablets plus metformin 850 milligram tablets

Intervention Type DRUG

letrozole

letrozole 5 milligram tablets

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No