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

Male Infertility Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01075334
• Other study ID #: porimore.CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 24, 2010
• Start date: February 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2010
• Source: Shaare Zedek Medical Center
• Contact: Avi Tsafrir, MD
• Phone: 972-6555111
• Email: avits[@]szmc.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Male
• Male Infertility

Intervention

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.
• Zinc and Folate Supplementation
500 Mcg Folic acid, 30-60 mg Zinc tablets/ day

Locations

Country	Name	City	State
Israel	Shaare-Zedek IVF and infertility unit	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy Rate	proportion of women becoming pregnancy following treatment with intrauterine insemination	3 Insemination cycles	No
Secondary	Sperm quality parameters		3 months	No