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

Infertility Poly Cystic Ovary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03181919
• Other study ID #: letrozole step-up protocol
• Status: Completed
• Phase: N/A
• First received: June 7, 2017
• Last updated: June 7, 2017
• Start date: January 1, 2016
• Est. completion date: March 1, 2017

Study information

• Verified date: June 2017
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 1, 2017
• Est. primary completion date: January 1, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility Poly Cystic Ovary

Intervention

Drug:
• Letrozole
Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature follicles		2 weeks
Secondary	Pregnancy rate		one month