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ACTIVE NOT RECRUITING
NCT03337360
NA

The Impact of a Nutritional Supplement (Impryl®) on Male Fertility

Sponsor: Radboud University Medical Center

View on ClinicalTrials.gov

Summary

Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples a male factor is involved. Male infertility is of multifactorial origin. In the past decade, the role of oxidative stress on sperm has been researched thoroughly and found to be the problem in 30% to 80% of male infertility cases. Impryl® is a nutritional supplement mainly consisting of vitamin B, which works on the metabolic system by activating the one carbon cycle and recycling of homocysteine without the use of any direct strong antioxidants. In this study the investigators want to determine the effectiveness of nutritional supplement Impryl® in men of infertile couples on ongoing pregnancy rate, with or without assisted reproduction technology (ART).

Key Details

Gender

MALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2018-04-23

Completion Date

2026-04-30

Last Updated

2025-04-04

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Impryl

Food supplement with betaine, cystine, zinc, niacin, folic acid (5MTHF-glucosamine), Vitamin B12 (cobalamin), Vitamin B6, Vitamin B2 (riboflavin)

OTHER

Placebo

Inactive ingredients, placebo

Locations (21)

Fertiliteitscentrum Voorburg

Voorburg, Gelderland, Netherlands

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Gelre Ziekenhuizen

Apeldoorn, Netherlands

Rijnstate

Arnhem, Netherlands

Maasziekenhuis Pantein

Boxmeer, Netherlands

Amphia ziekenhuis

Breda, Netherlands

Slingeland Ziekenhuis

Doetinchem, Netherlands

Albert Schweitzer ziekenhuis

Dordrecht, Netherlands

Catharina Ziekenhuis Eindhoven

Eindhoven, Netherlands

Nij Geertgen

Elsendorp, Netherlands

Treant ziekenhuis Scheper

Emmen, Netherlands

Nij Linge

Gorinchem, Netherlands

Medisch Centrum Kinderwens

Leiderdorp, Netherlands

Radboudumc

Nijmegen, Netherlands

Bravis Ziekenhuis

Roosendaal, Netherlands

Franciscus Gasthuis en Vlietland

Rotterdam, Netherlands

Maasstad ziekenhuis

Rotterdam, Netherlands

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

Bernhoven Ziekenhuis

Uden, Netherlands

Máxima Medisch Centrum

Veldhoven, Netherlands

Nij Barrahus

Wolvega, Netherlands