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
  Purpose

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 Intervention
Male Infertility
Dietary Supplement: Porimore - A Carnitine based food supplement
Dietary Supplement: Zinc and Folate Supplementation

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

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • Pregnancy Rate [ Time Frame: 3 Insemination cycles ] [ Designated as safety issue: No ]
    proportion of women becoming pregnancy following treatment with intrauterine insemination


Secondary Outcome Measures:
  • Sperm quality parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075334

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

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

Publications:
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
Study First Received: February 24, 2010
Last Updated: February 24, 2010
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Infertility, Male
Infertility
Genital Diseases, Male
Genital Diseases, Female
Carnitine
Vitamin B Complex
Zinc
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Trace Elements

ClinicalTrials.gov processed this record on October 19, 2014