Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
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|ClinicalTrials.gov Identifier: NCT03181919|
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infertility Poly Cystic Ovary||Drug: Letrozole||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||January 1, 2017|
|Actual Study Completion Date :||March 1, 2017|
Experimental: Step Up group
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.
Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
No Intervention: Control group
includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.
- Number of mature follicles [ Time Frame: 2 weeks ]
- Pregnancy rate [ Time Frame: one month ]