Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 24, 2010
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 25, 2010
February 1, 2010
Same day
February 24, 2010
February 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy Rate
proportion of women becoming pregnancy following treatment with intrauterine insemination
3 Insemination cycles
Secondary Outcomes (1)
Sperm quality parameters
3 months
Study Arms (2)
Porimore arm
EXPERIMENTALInfertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.
Folate and Zinc
ACTIVE COMPARATORInterventions
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.
500 Mcg Folic acid, 30-60 mg Zinc tablets/ day
Eligibility Criteria
You may qualify if:
- infertility
- at least one abnormal sperm quality parameter
- female age \< 35
- normal ovarian reserve
You may not qualify if:
- known allergy to one of the food additives planned for treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shaare-Zedek IVF and infertility unit
Jerusalem, 91031, Israel
Related Publications (2)
Isidori AM, Pozza C, Gianfrilli D, Isidori A. Medical treatment to improve sperm quality. Reprod Biomed Online. 2006 Jun;12(6):704-14. doi: 10.1016/s1472-6483(10)61082-6.
PMID: 16792845BACKGROUNDde Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.
PMID: 35506389DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 24, 2010
First Posted
February 25, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2010
Study Completion
December 1, 2012
Last Updated
February 25, 2010
Record last verified: 2010-02