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

NCT ID: NCT01075334

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Porimore arm

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

Group Type EXPERIMENTAL

Porimore - A Carnitine based food supplement

Intervention Type DIETARY_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.

Folate and Zinc

Group Type ACTIVE_COMPARATOR

Zinc and Folate Supplementation

Intervention Type DIETARY_SUPPLEMENT

500 Mcg Folic acid, 30-60 mg Zinc tablets/ day

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Zinc and Folate Supplementation

500 Mcg Folic acid, 30-60 mg Zinc tablets/ day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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IVF Unit, Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Shaare-Zedek IVF and infertility unit

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Avi Tsafrir, MD

Role: CONTACT

972-6555111

References

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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.

Reference Type BACKGROUND
PMID: 16792845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35506389 (View on PubMed)

Other Identifiers

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porimore.CTIL

Identifier Type: -

Identifier Source: org_study_id

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