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

Not Applicable

Completed

• Conditions: Infertility Poly Cystic Ovary
• Interventions: Drug: Letrozole

• Registration Number: NCT03181919
• Lead Sponsor: Benha University

Brief 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).

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2017-03-01
• Status Verified: 2017-06
• Study First Submitted: 2017-06-07
• Study First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Study First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Step Up group	Letrozole	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.

Primary Outcome Measures

Name	Time	Method
Number of mature follicles	2 weeks

Secondary Outcome Measures

Name	Time	Method
Pregnancy rate	one month