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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
  Purpose

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 Intervention
Oligospermia
Dietary Supplement: Vitamale

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamale Dietary Supplement: Vitamale
men will receive the vitamale dietary supplement compared to a sham pill
Other Name: 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 Name: amino acid minerals and vitamin supplement

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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01520584

Locations
Israel
Hillel Yaffe Medical Center
Hadera, Israel, 38101
Sponsors and Collaborators
Hillel Yaffe Medical Center
Investigators
Principal Investigator: Dana Irge, DR Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01520584     History of Changes
Other Study ID Numbers: 0103-10
Study First Received: January 14, 2012
Last Updated: January 25, 2012
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Oligospermia
Genital Diseases, Male
Infertility
Infertility, Male
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014