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 Applicable
- Conditions
- Male Infertility
- Interventions
- Dietary Supplement: Porimore - A Carnitine based food supplementDietary Supplement: Zinc and Folate Supplementation
- Registration Number
- NCT01075334
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 100
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Porimore arm Porimore - A Carnitine based food supplement Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed. Folate and Zinc Zinc and Folate Supplementation -
- Primary Outcome Measures
Name Time Method Pregnancy Rate 3 Insemination cycles proportion of women becoming pregnancy following treatment with intrauterine insemination
- Secondary Outcome Measures
Name Time Method Sperm quality parameters 3 months
Trial Locations
- Locations (1)
Shaare-Zedek IVF and infertility unit
🇮🇱Jerusalem, Israel