Induction of Ovulation Using Clomiphene Citrate and N-acetyl Cysteine Versus Letrozole
1 other identifier
interventional
100
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2016
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedAugust 7, 2017
August 1, 2017
1.2 years
August 3, 2017
August 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
rate of ovulation
ultrasound evaluation
3 months
Study Arms (2)
Lertozole
EXPERIMENTALoral tablets 5 mg start from third day cycle for 5 days
clomiphene plus N- acetyl cystiene
ACTIVE COMPARATORclomiphene 100 mg plus N-acetyl cystiene 600 mg start from third day cycle for 5 days
Interventions
Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
Eligibility Criteria
You may qualify if:
- All primary and secondary. Infertility due to anovulation
You may not qualify if:
- Male factor infertility, tubal factor.
- Endocrineopathy
- Hypothyrodism
- Morbid obesity
- Under weight
- Patient with previous surgery including drilling of ovary, Clomiphene Citrate resistant to ovulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
August 3, 2017
First Posted
August 7, 2017
Study Start
February 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
August 7, 2017
Record last verified: 2017-08