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

Study Overview
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Brief Summary
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the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS

Detailed Description
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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).

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

Conditions
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Infertility Poly Cystic Ovary

Intervention / Treatment
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* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step Up group<br>includes females taking Letrozole 5 mg tablets in a step-up protocol 5 mg in day one, 7.5 in day 2, 10 mg in days 3, 12.5 mg in day 4 and 15 in day 5 started in day 3 to day 7 of menstrual cycle. | Drug: Letrozole<br>* Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.<br>|
| No Intervention: Control group<br>includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature follicles |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate |  | one month |