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Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality

Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT01520584
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
48
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The vitamin,minerals and amino acid supplementation for 3 months will improve the semen parameters,fertilization rate and embryo quality in subfertile men undergoing IVF treatment

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Vitamale
 N/A

Detailed Description

With the supplement intake containing amino acids, vitamins and minerals designed to improve sperm parameters, the couples undergoing IVF treatment will benefit as the change and improvement of sperm parameters will increase the fertilization rate and improve the embryo quality thus allowing shorter time for pregnancy achievement and less frustration with long duration of treatments

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Official Title:
Vitamins ,Minerals and Amino Acids Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality. A Double Blind Randomized Controlled Trial
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Jan 1, 2014
Anticipated Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: vitamale

Dietary Supplement: Vitamale
men will receive the vitamale dietary supplement compared to a sham pill
Other Names:
  • amino acid minerals and vitamin supplement

    		•
    Placebo Comparator: sham pill

    Dietary Supplement: Vitamale
    men will receive the vitamale dietary supplement compared to a sham pill
    Other Names:
  • amino acid minerals and vitamin supplement

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sperm parameters [3 months of treatment]

      Men suffering from a "male factor" problem and after one failed IVF treatment will be given the supplement for 3 months after which the sperm parametrs will be evaluated and compared to pre-supplement data and later the embryo quality and fertilization rate will reviewed analyzed and compared

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • healthy male age 20-50

    • at least one IVF cycle without pregnancy

    • sperm parameters:

    • Oligospermia 5-20*106

    • Teratospermia 6-14% normal forms

    • Asthenospermia <30% motility

    Exclusion Criteria:

    • female factor infertility

    • age > 50 or under 20

    • testicular problem on physical examination

    • history of malignancy and /or chemotherapy

    • usage of antiandrogen/testosterone

    • history of drug abuse/alcohol

    • a known endocrinological problem

    • current STD or genitourinary infection

    • Retrograde Ejaculation

    • Y chromosome microdeletion

    • Karyotype abnormalities

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hillel Yaffe Medical Center Hadera Israel 38101

    Sponsors and Collaborators

    • Hillel Yaffe Medical Center

    Investigators

    • Principal Investigator: Dana Irge, DR, Hillel Yaffe Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hillel Yaffe Medical Center
    ClinicalTrials.gov Identifier:
    NCT01520584
    Other Study ID Numbers:
    • 0103-10
    First Posted:
    Jan 30, 2012
    Last Update Posted:
    Jan 30, 2012
    Last Verified:
    Jan 1, 2012
    Additional relevant MeSH terms:
    Oligospermia
    Vitamins

    Study Results

    No Results Posted as of Jan 30, 2012