Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS

The current study was conducted in private outpatient clinic after being approved by the medical ethics committee. The study is a prospective randomized study consisting of 90 Egyptian patients diagnosed as having infertility with pcos .

Sample size determination:

Group sample sizes of 42 and 42 achieve 80% power based on study finding carried out by (Galal et al., 2014) to detect a difference of 0.7 between the null hypothesis that both group means are 2.2 and the alternative hypothesis that the mean of group 2 is 1.5 with known group standard deviations of 1.5 and 0.6 and with a significance level (alpha) of 0.05000 using a two-sided Mann-Whitney test assuming that the actual distribution is uniform.

Sample size was calculated by PASS 11 Computer program for sample size calculation.

Taking into consideration 10% drop out rate, the sample size will be increased to 45 patients in group I and another 45 patients in group II.

Patients were divided into two groups with randomization sheet:

Group (I): includes 45 females taking Letrozole (old regimen).

Group (II): includes 45 females taking Letrozole 5 mg tab in a step-up protocol (new regimen).

Inclusion criteria

• Age: 20 -37 years old.
• No conception for at least one year.
• Diagnosis of PCO as established by Rotterdam criteria, endometriosis diagnosed by laparoscope or unexplained infertility.

Exclusion criteria

• Age < 20 and > 35 years old.
• Uterine pathology e.g. fibroid or ovarian cyst.
• Hyperprolactinemia, hypo or hyperthyroidism.
• Impaired hepatic or renal function.
• History of hypersensitivity to study drugs.