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

June 7, 2017 updated by: Dr. Abou Bakr Mohamed El Nashaar, Benha University
the aim of the study is to compare between the step-up and conventional protocols in ovulation induction in infertile women with PCOS

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Letrozole
Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
No Intervention: Control group
includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of mature follicles
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: one month
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • letrozole step-up protocol

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publish a manuscript

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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