Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Benha University
- Enrollment
- 90
- Primary Endpoint
- Number of mature follicles
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Letrozole (Drug)
Outcomes
Primary Outcomes
Number of mature follicles
Time Frame: 2 weeks
Secondary Outcomes
- Pregnancy rate(one month)
Investigators
Dr. Abou Bakr Mohamed El Nashaar
Professor of obstetric and gynecology Benha University
Benha University