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Adding L-carnitine in Clomiphene Resistant Polycystic Ovary Improves the Quality of Ovulation and the Pregnancy Outcome

Sponsor
Woman's Health University Hospital, Egypt (Other)
Overall Status
Unknown status
CT.gov ID
NCT01665547
Collaborator
(none)
157
Enrollment
1
Arm
14
Duration (Months)

Study Details

Study Description

Brief Summary

Adding L-carnitine is more successful than clomiphene as a first line therapy for ovulation induction in women with clomiphene resistant PCOS

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
157 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Adding L-carnitine in Clomiphene Resistant Pco Improves the Quality of Ovulation and the Pregnancy Outcome,a Randomized Clinical Trial
Study Start Date :
Jul 1, 2012
Actual Primary Completion Date :
Aug 1, 2013
Anticipated Study Completion Date :
Sep 1, 2013

Arms and Interventions

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

Drug: l-carnitine
3gm l-carnitine from day 1 to day 12 of the menstrual cycle
Other Names:
  • carivita,l-carnitol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ovulation induction [0ne year]

      is to study the efficacy of l-carnitine in inducing ovulation in clomiphene resistant pco

    Secondary Outcome Measures

    1. pregnancy [0ne year]

      the occurrence of pregnancy and the rate of continuation of pregnancy till end of the first trimester

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Woman's Health University Hospital, Egypt

    Investigators

    • Principal Investigator: Alaa M Ismail, M.D, Women's Health Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    alaa eldeen mahmoud ismail, assistant professor, Woman's Health University Hospital, Egypt
    ClinicalTrials.gov Identifier:
    NCT01665547
    Other Study ID Numbers:
    • lcpco
    First Posted:
    Aug 15, 2012
    Last Update Posted:
    Sep 10, 2013
    Last Verified:
    Sep 1, 2013
    Keywords provided by alaa eldeen mahmoud ismail, assistant professor, Woman's Health University Hospital, Egypt
    clomiphene resistant
    pcos
    induction of ovulation
    l-carnitine

    Study Results

    No Results Posted as of Sep 10, 2013