NCT03181919

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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

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).

Conditions

• Infertility Poly Cystic Ovary

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2017-06-09
• Last updated: 2017-06-09