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Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?

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ClinicalTrials.gov Identifier: NCT01075334
Recruitment Status : Unknown
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
Many cases of male infertility are poorly understood and regarded as unexplained. Therefore, a etiological treatment for this condition can not be offered in most cases. A beneficial effect on sperm motility was found in trails using antioxidants such as carnitine, zinc and folic acid. However, most studies lacked a sufficient power to detect a significant effect on pregnancy rates. In this study, infertile men with abnormal sperm quality parameters will be randomized to receive either carnitine-based food supplement (Porimore) or folate and Zinc Tablets.

Condition or disease Intervention/treatment
Male Infertility Dietary Supplement: Porimore - A Carnitine based food supplement Dietary Supplement: Zinc and Folate Supplementation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2010
Primary Completion Date : February 2010
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Porimore arm
Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.
Dietary Supplement: Porimore - A Carnitine based food supplement
A daily dose of 2 grams L-carnitine, 1 gr acetyl L-carnitine, 500mg Vitamin C, 400 IU vitamin E, 60 mg Q10, 30mg Zinc Picolinate, 500mcg Folic Acid, 200 Mcg Selenium, 100 MCG Vitamin B12.
Active Comparator: Folate and Zinc Dietary Supplement: Zinc and Folate Supplementation
500 Mcg Folic acid, 30-60 mg Zinc tablets/ day

Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 3 Insemination cycles ]
    proportion of women becoming pregnancy following treatment with intrauterine insemination

Secondary Outcome Measures :
  1. Sperm quality parameters [ Time Frame: 3 months ]

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • infertility
  • at least one abnormal sperm quality parameter
  • female age < 35
  • normal ovarian reserve

Exclusion Criteria:

  • known allergy to one of the food additives planned for treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075334

Contact: Avi Tsafrir, MD 972-6555111 avits@szmc.org.il

Shaare-Zedek IVF and infertility unit Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Avi Tsafrir, MD         
Sponsors and Collaborators
Shaare Zedek Medical Center

Responsible Party: Avi Tsafrir, MD, IVF Unit, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT01075334     History of Changes
Other Study ID Numbers: porimore.CTIL
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: February 2010

Keywords provided by Shaare Zedek Medical Center:
male infertility
food supplementation

Additional relevant MeSH terms:
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Folic Acid
Vitamin B Complex
Trace Elements
Growth Substances
Physiological Effects of Drugs