The Impact of a Nutritional Supplement (Impryl®) on Male Fertility
NCT ID: NCT03337360
Last Updated: 2025-04-04
Study Results
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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ACTIVE_NOT_RECRUITING
NA
1200 participants
INTERVENTIONAL
2018-04-23
2026-04-30
Brief Summary
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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).
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Detailed Description
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Objective: To determine the effectiveness of nutritional supplement Impryl® in men of infertile couples on ongoing pregnancy rate, with or without assisted reproduction technology (ART).
Study design: Multicentre, randomised double blind placebo controlled clinical trial/superiority study.
Study population: All participants in this study are male adults, age 18-50 years, part of a couple that is diagnosed with infertility, regardless the outcome of semen analysis. The couple will either start or is already started with fertility treatment, i.e. expectative management (EM, duration 6 months), intra-uterine insemination (IUI) with or without ovarian stimulation (mild ovarian hyperstimulation (MOH) or ovulation induction (OI)), either in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment.
Intervention: Impryl® or placebo, with identical appearance one tablet each day for a total duration of maximal 6 months. Patients can start directly with study medication and fertility treatment (or to conceive spontaneously).
Main study parameters/endpoints: The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥ 10-12 weeks. Secondary outcomes are change in semen parameters between baseline and 3 months intervention in IUI/IVF/ICSI group, based on (pre-wash) total motile sperm count (TMSC), leading to a change in treatment category Furthermore the occurrence of pregnancy, time to pregnancy, embryo fertilization rate in IVF/ICSI, embryo-utilization rate in IVF/ICSI, number of miscarriages and live birth rate are documented within the study period. The occurrence of adverse events will be reported.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Impryl
One tablet daily for 6 months
Impryl
Food supplement with betaine, cystine, zinc, niacin, folic acid (5MTHF-glucosamine), Vitamin B12 (cobalamin), Vitamin B6, Vitamin B2 (riboflavin)
Placebo
One tablet daily for 6 months
Placebo
Inactive ingredients, placebo
Interventions
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Impryl
Food supplement with betaine, cystine, zinc, niacin, folic acid (5MTHF-glucosamine), Vitamin B12 (cobalamin), Vitamin B6, Vitamin B2 (riboflavin)
Placebo
Inactive ingredients, placebo
Eligibility Criteria
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Inclusion Criteria
Furthermore:
* Male with age 18-50 years
* Female partner with age 18-43 years
* Willing and able to give informed consent
Exclusion Criteria
* Use of donor-, cryopreserved- or electro-ejaculated semen
* Ovulation induction (OI) without IUI
* IVF for an absolute tubal factor
* Embryo-transfers after cryopreservation
* Embryo-transfer after pre-implantation genetic diagnosis
* Known genetic abnormalities related to infertility
* Known urological abnormality such as a varicocele or bilateral cryptorchism
* Use of other vitamin supplements
18 Years
50 Years
MALE
Yes
Sponsors
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Goodlife Fertility B.V.
UNKNOWN
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Annemiek Nap, Prof.dr.
Role: STUDY_DIRECTOR
Gynecologist, head of department of Obstetrics and Gynaecology
Annemiek Nap, Prof MD PhD
Role: PRINCIPAL_INVESTIGATOR
Gynecologist, head of department of Obstetrics and Gynecology
Locations
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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
Countries
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References
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Iwasaki A, Gagnon C. Formation of reactive oxygen species in spermatozoa of infertile patients. Fertil Steril. 1992 Feb;57(2):409-16. doi: 10.1016/s0015-0282(16)54855-9.
Zini A, de Lamirande E, Gagnon C. Reactive oxygen species in semen of infertile patients: levels of superoxide dismutase- and catalase-like activities in seminal plasma and spermatozoa. Int J Androl. 1993 Jun;16(3):183-8. doi: 10.1111/j.1365-2605.1993.tb01177.x.
Shekarriz M, Thomas AJ Jr, Agarwal A. Incidence and level of seminal reactive oxygen species in normal men. Urology. 1995 Jan;45(1):103-7. doi: 10.1016/s0090-4295(95)97088-6.
Agarwal A, Prabakaran S, Allamaneni S. What an andrologist/urologist should know about free radicals and why. Urology. 2006 Jan;67(1):2-8. doi: 10.1016/j.urology.2005.07.012. No abstract available.
Tremellen K. Oxidative stress and male infertility--a clinical perspective. Hum Reprod Update. 2008 May-Jun;14(3):243-58. doi: 10.1093/humupd/dmn004. Epub 2008 Feb 14.
Showell MG, Mackenzie-Proctor R, Brown J, Yazdani A, Stankiewicz MT, Hart RJ. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2014;(12):CD007411. doi: 10.1002/14651858.CD007411.pub3. Epub 2014 Dec 15.
Dattilo M, Cornet D, Amar E, Cohen M, Menezo Y. The importance of the one carbon cycle nutritional support in human male fertility: a preliminary clinical report. Reprod Biol Endocrinol. 2014 Jul 29;12:71. doi: 10.1186/1477-7827-12-71.
Dattilo M, D'Amato G, Caroppo E, Menezo Y. Improvement of gamete quality by stimulating and feeding the endogenous antioxidant system: mechanisms, clinical results, insights on gene-environment interactions and the role of diet. J Assist Reprod Genet. 2016 Dec;33(12):1633-1648. doi: 10.1007/s10815-016-0767-4. Epub 2016 Jul 16.
de Ligny WR, de Bruin JP, Smits RM, Goovaerts IGF, Peeters K, Nap AW, Boxmeer JC, Donker RB, Schoonenberg M, Koks CAM, van Rumste MME, Visser J, Gielen SCJP, Boomsma CM, Smeenk JMJ, van Oppenraaij RHF, Cox T, Janse F, Muller LT, Brink-van der Vlugt JJ, Braat DDM, Fleischer K. Antioxidant Treatment and the Chance to Conceive in Men Seeking Fertility Care: The SUMMER Randomized Clinical Trial. JAMA Netw Open. 2025 Sep 2;8(9):e2532405. doi: 10.1001/jamanetworkopen.2025.32405.
Smits R, D'Hauwers K, IntHout J, Braat D, Fleischer K. Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial). BMJ Open. 2020 Jul 2;10(7):e035069. doi: 10.1136/bmjopen-2019-035069.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Website Impryl
Other Identifiers
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NTR6551
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL61414.091.17
Identifier Type: -
Identifier Source: org_study_id
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