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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    1200
  • sponsor
    Radboud University
Updated on 4 March 2022
Accepts healthy volunteers

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).

Description

Rationale: 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. 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 which works on the metabolic system and regulation of oxidative stress by activating the 1-Carbon cycle and therefore recycling of homocysteine.

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.

Details
Condition Male Subfertility
Treatment Placebo, Impryl
Clinical Study IdentifierNCT03337360
SponsorRadboud University
Last Modified on4 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Couples with failure to conceive for at least 12 months and starting with EM
or Couples starting with 1st/ 2nd/3rd cycle of IUI (with/without ovarian
stimulation) or Couples starting with 1st/ 2nd/3rd cycle of IVF/ICSI
Furthermore
Male with age 18-50 years
Female partner with age 18-43 years
Willing and able to give informed consent

Exclusion Criteria

Planned or performed diagnostic testicular biopsy (TESE) or percutaneous epididymal sperm aspiration (PESA)
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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