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

Shaare Zedek Medical Center

Status: Unknown

Conditions: Male Infertility

Treatments: Dietary Supplement: Porimore - A Carnitine based food supplement; Dietary Supplement: Zinc and Folate Supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01075334

porimore.CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Porimore arm

Experimental group

Description:

Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.

Treatment:

Dietary Supplement: Porimore - A Carnitine based food supplement

Folate and Zinc

Active Comparator group

Treatment:

Dietary Supplement: Zinc and Folate Supplementation