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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03181919
Enrollment
90
Registered
2017-06-09
Start date
2016-01-01
Completion date
2017-03-01
Last updated
2017-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility Poly Cystic Ovary

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).

Interventions

DRUGLetrozole

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

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 35 Years
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.

Design outcomes

Primary

MeasureTime frame
Number of mature follicles2 weeks

Secondary

MeasureTime frame
Pregnancy rateone month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026