Back to resultsIs a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
Primary Purpose
Male Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Porimore - A Carnitine based food supplement
Zinc and Folate Supplementation
Sponsored by
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring sperm, male infertility, Carnitine, food supplementation, insemination
Eligibility 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
Sites / Locations
- Shaare-Zedek IVF and infertility unitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Porimore arm
Folate and Zinc
Arm Description
Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.
Outcomes
Primary Outcome Measures
Pregnancy Rate
proportion of women becoming pregnancy following treatment with intrauterine insemination
Secondary Outcome Measures
Sperm quality parameters
Full Information
NCT ID
NCT01075334
First Posted
February 24, 2010
Last Updated
February 24, 2010
Sponsor
Shaare Zedek Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01075334
Brief Title
Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shaare Zedek Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility
Keywords
sperm, male infertility, Carnitine, food supplementation, insemination
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Porimore arm
Arm Type
Experimental
Arm Description
Infertile men will receive 'Porimore' tablets for a period of time in which three intrauterine insemination cycles will be performed.
Arm Title
Folate and Zinc
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Porimore - A Carnitine based food supplement
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc and Folate Supplementation
Intervention Description
500 Mcg Folic acid, 30-60 mg Zinc tablets/ day
Primary Outcome Measure Information:
Title
Pregnancy Rate
Description
proportion of women becoming pregnancy following treatment with intrauterine insemination
Time Frame
3 Insemination cycles
Secondary Outcome Measure Information:
Title
Sperm quality parameters
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Tsafrir, MD
Phone
972-6555111
Email
avits@szmc.org.il
Facility Information:
Facility Name
Shaare-Zedek IVF and infertility unit
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avi Tsafrir, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16792845
Citation
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.
Results Reference
background
PubMed Identifier
35506389
Citation
de 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.
Results Reference
derived
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Is a Carnitine Based Food Supplement (PorimoreTM) for Infertile Men Superior to Folate and Zinc With Regard to Pregnancy Rates in Intrauterine Insemination Cycles?
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