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

This study is not yet open for participant recruitment.
Verified January 2012 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01520584
First received: January 14, 2012
Last updated: January 25, 2012
Last verified: January 2012
History of Changes

January 14, 2012
January 25, 2012
January 2012
January 2014   (final data collection date for primary outcome measure)
Sperm parameters [ Time Frame: 3 months of treatment ] [ Designated as safety issue: Yes ]
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
Same as current
Complete list of historical versions of study NCT01520584 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Supplement Intake in Infertile Men;the Effect on Sperm Parameters,Fertilization Rate and Embryo Quality
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

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

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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Oligospermia
Dietary Supplement: Vitamale
men will receive the vitamale dietary supplement compared to a sham pill
Other Name: amino acid minerals and vitamin supplement
  • Active Comparator: vitamale
    Intervention: Dietary Supplement: Vitamale
  • Placebo Comparator: sham pill
    Intervention: Dietary Supplement: Vitamale
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
January 2016
January 2014   (final data collection date for primary outcome measure)

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
Male
20 Years to 50 Years
Yes
Not Provided
Israel
 
NCT01520584
0103-10
No
Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
Not Provided
Principal Investigator: Dana Irge, DR Hillel Yaffe Medical Center
Hillel Yaffe Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP