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

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ClinicalTrials.gov Identifier: NCT03630341
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Drug: Clomiphene Citrate 50mg Drug: L-carnitine Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adding L-Carnitine to Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovary Syndrome
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : March 31, 2018
Actual Study Completion Date : May 2018


Arm Intervention/treatment
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.
Drug: Clomiphene Citrate 50mg
oral 50 mg tablets

Drug: L-carnitine
1000 mg oral tablet

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.
Drug: Clomiphene Citrate 50mg
oral 50 mg tablets

Drug: Placebo Oral Tablet
oral tablets identical to L-carnitine




Primary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03630341     History of Changes
Other Study ID Numbers: LCCC
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators