- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01665547
Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome
September 9, 2013 updated by: alaa eldeen mahmoud ismail, Woman's Health University Hospital, Egypt
Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial
Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS
Study Overview
Detailed Description
Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included.
Study Type
Interventional
Enrollment (Anticipated)
157
Phase
- Phase 4
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
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients younger than 35 years, presenting with primary or secondary infertility following regular intercourse for at least 1 year and diagnosed with PCO according to Rotterdam's criteria who had received five unsuccessful clomiphene citrate-timed intercourse stimulation cycles were included. The diagnosis was based on a complete history taking, physical examination and a paper documented complete infertility work-up within the previous 6 months, either conducted within the setting of the hospital or at a licensed infertility management clinic.
Exclusion Criteria:
- age more than 40 years,
- tubal,uterine or male factor infertility
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: l-carnitine
adding 3gm l-carnitine from day 1 to day 12 of induced the menstrual cycle by 50 mg clomiphene
|
3gm l-carnitine from day 1 to day 12 of the menstrual cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ovulation induction
Time Frame: 0ne year
|
is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco
|
0ne year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pregnancy
Time Frame: 0ne year
|
the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester
|
0ne year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alaa M Ismail, M.D, Women's Health Hospital
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
July 1, 2012
Primary Completion (ACTUAL)
August 1, 2013
Study Completion (ANTICIPATED)
September 1, 2013
Study Registration Dates
First Submitted
July 13, 2012
First Submitted That Met QC Criteria
August 9, 2012
First Posted (ESTIMATE)
August 15, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
September 10, 2013
Last Update Submitted That Met QC Criteria
September 9, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- lcpco
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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