Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181919
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Abou Bakr Mohamed El Nashaar, Benha University

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

Condition or disease Intervention/treatment Phase
Infertility Poly Cystic Ovary Drug: Letrozole Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : March 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Letrozole

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.



Primary Outcome Measures :
  1. Number of mature follicles [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Pregnancy rate [ Time Frame: one month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Layout table for additonal information
Responsible Party: Dr. Abou Bakr Mohamed El Nashaar, Professor of obstetric and gynecology Benha University, Benha University
ClinicalTrials.gov Identifier: NCT03181919    
Other Study ID Numbers: letrozole step-up protocol
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publish a manuscript

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs