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

NCT ID: NCT01520584

Last Updated: 2012-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Oligospermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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vitamale

Group Type ACTIVE_COMPARATOR

Vitamale

Intervention Type DIETARY_SUPPLEMENT

men will receive the vitamale dietary supplement compared to a sham pill

sham pill

Group Type PLACEBO_COMPARATOR

Vitamale

Intervention Type DIETARY_SUPPLEMENT

men will receive the vitamale dietary supplement compared to a sham pill

Interventions

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Vitamale

men will receive the vitamale dietary supplement compared to a sham pill

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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amino acid minerals and vitamin supplement

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dana Irge, DR

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 35506389 (View on PubMed)

Other Identifiers

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0103-10

Identifier Type: -

Identifier Source: org_study_id

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