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
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
Longer than P75 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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2012
CompletedFirst Posted
Study publicly available on registry
January 30, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 30, 2012
January 1, 2012
2 years
January 14, 2012
January 25, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Sperm parameters
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
3 months of treatment
Study Arms (2)
vitamale
ACTIVE COMPARATORsham pill
PLACEBO COMPARATORInterventions
men will receive the vitamale dietary supplement compared to a sham pill
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hillel Yaffe Medical Center
Hadera, 38101, Israel
Related Publications (1)
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.
PMID: 35506389DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dana Irge, DR
Hillel Yaffe Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2012
First Posted
January 30, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2016
Last Updated
January 30, 2012
Record last verified: 2012-01