Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome

Overview

Polycystic ovary syndrome is one of the most common endocrine disorders, affecting about 6-10% of women in their reproductive age. Anovulation and hyperandrogenism are often present together with hyperinsulinaemia and insulin resistance

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 31, 2018

Interventions

  • Drug: Clomiphene Citrate 50mg
    • oral 50 mg tablets
  • Drug: L-carnitine
    • 1000 mg oral tablet
  • Drug: Placebo Oral Tablet
    • oral tablets identical to L-carnitine

Arms, Groups and Cohorts

  • Experimental: study group
    • This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral carnitine 1g tablet, three times per day from the third day until the day of the pregnancy test.
  • Active Comparator: control group
    • This group will receive oral clomiphene citrate 50 mg tablet, two times per day from the third day of the cycle until the seventh day of the cycle plus oral placebo tablet, three times per day from the third day until the day of the pregnancy test.

Clinical Trial Outcome Measures

Primary Measures

  • clinical pregnancy rate
    • Time Frame: 1 month
    • visible intra-uterine gestational sac, with a positive fetal heart beat, viewed during a transvaginal ultrasound (when the b-hCG concentration was more than 1500 IU/l)

Participating in This Clinical Trial

Inclusion Criteria

  • Primary or secondary infertility. – Normal Hysterosalpingo-graphy – Normal Semen analysis of the husband. Exclusion Criteria:

  • Patient's refusal. – Male factors of infertility and/or abnormal Hysterosalpingo-graphy – Hyperprolactinemia (prolactin ≥ 22 ng/dl). – FSH on day 3 > 15 mIU/mL. – Gross ovarian pathology diagnosed by ultrasound.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Mohamed Abbas, Principal investigator – Assiut University

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