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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT01075334
First received: February 24, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted

February 24, 2010
February 24, 2010
February 2010
February 2010   (final data collection date for primary outcome measure)
Pregnancy Rate [ Time Frame: 3 Insemination cycles ] [ Designated as safety issue: No ]
proportion of women becoming pregnancy following treatment with intrauterine insemination
Same as current
No Changes Posted
Sperm quality parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Male Infertility
  • 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.
  • Dietary Supplement: Zinc and Folate Supplementation
    500 Mcg Folic acid, 30-60 mg Zinc tablets/ day
  • Experimental: Porimore arm
    Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.
    Intervention: Dietary Supplement: Porimore - A Carnitine based food supplement
  • Active Comparator: Folate and Zinc
    Intervention: Dietary Supplement: Zinc and Folate Supplementation
Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2012
February 2010   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact: Avi Tsafrir, MD 972-6555111 avits@szmc.org.il
Israel
 
NCT01075334
porimore.CTIL
No
Avi Tsafrir, MD, IVF Unit, Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
Not Provided
Not Provided
Shaare Zedek Medical Center
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP