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

Oligospermia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01520584
• Other study ID #: 0103-10
• Status: Not yet recruiting
• Phase: N/A
• First received: January 14, 2012
• Last updated: January 25, 2012
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2012
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Related Conditions & MeSH terms

• Oligospermia

Intervention

Dietary Supplement:
• Vitamale
men will receive the vitamale dietary supplement compared to a sham pill

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes