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

NCT ID: NCT03181919

Last Updated: 2017-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-01
• Study Completion Date: 2017-03-01

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).

Conditions

Infertility Poly Cystic Ovary

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Letrozole

Intervention Type: DRUG

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

Control group

includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Letrozole

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Abou Bakr Mohamed El Nashaar

Professor of obstetric and gynecology Benha University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

letrozole step-up protocol

Identifier Type: -

Identifier Source: org_study_id