Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Primary Purpose
Infertility Poly Cystic Ovary
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Letrozole
Sponsored by
About this trial
This is an interventional treatment trial for Infertility Poly Cystic Ovary
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Step Up group
Control group
Arm Description
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.
includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.
Outcomes
Primary Outcome Measures
Number of mature follicles
Secondary Outcome Measures
Pregnancy rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03181919
Brief Title
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Official Title
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
March 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility Poly Cystic Ovary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step Up group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
includes females taking Letrozole 5 mg tab orally once daily started in day 3 to day 7 of menstrual cycle.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
Primary Outcome Measure Information:
Title
Number of mature follicles
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
one month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publish a manuscript
Learn more about this trial
Letrozole Step-up Protocol for Ovulation Induction in Infertile Women With PCOS
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