Letrozole in Clomiphene Resistant Infertile Women With Polycystic Ovarian Syndrome

Assiut University

Status and phase: Enrolling; Phase 3

Conditions: Infertility, Female

Treatments: Drug: letrozole; Drug: letrozole plus metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT03135301

LET

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

letrozole plus metformin

Experimental group

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

Treatment:

Drug: letrozole plus metformin

letrozole

Active Comparator group

Description:

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

Treatment:

Drug: letrozole