Back to resultsInduction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Letrozole
Clomiphene Citrate plus N acetyl cystine
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- All primary and secondary. Infertility due to anovulation
Exclusion Criteria:
- Male factor infertility, tubal factor.
- Endocrineopathy
- Hypothyrodism
- Morbid obesity
- Under weight
- Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lertozole
clomiphene plus N- acetyl cystiene
Arm Description
oral tablets 5 mg start from third day cycle for 5 days
clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days
Outcomes
Primary Outcome Measures
rate of ovulation
ultrasound evaluation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03241472
Brief Title
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
Official Title
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infertility is defined as a couple's inability to become pregnant after one year of unprotected intercourse in women 35 years old and younger, and for six months in women over age 35 years. In any given year, about 15 percent of couples in North America and Europe who are trying to conceive are infertile
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lertozole
Arm Type
Experimental
Arm Description
oral tablets 5 mg start from third day cycle for 5 days
Arm Title
clomiphene plus N- acetyl cystiene
Arm Type
Active Comparator
Arm Description
clomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
oral tablets 5 mg
Intervention Type
Drug
Intervention Name(s)
Clomiphene Citrate plus N acetyl cystine
Intervention Description
Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
Primary Outcome Measure Information:
Title
rate of ovulation
Description
ultrasound evaluation
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All primary and secondary. Infertility due to anovulation
Exclusion Criteria:
Male factor infertility, tubal factor.
Endocrineopathy
Hypothyrodism
Morbid obesity
Under weight
Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
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