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Search / Trial NCT03337360

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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Nov 6, 2017

Trial Information

Current as of May 02, 2025

Active, not recruiting

Keywords

Fertility Male Subfertility Foodsupplement Oxidative Stress

ClinConnect Summary

This clinical trial is investigating the effects of a nutritional supplement called Impryl® on male fertility, specifically for men who are part of couples struggling to conceive. Infertility affects many couples, and in about half of these cases, a male factor plays a role. The study aims to see if taking Impryl®, which contains vitamin B and supports the body's metabolism, can help increase the chances of pregnancy for these couples, whether they are using assisted reproductive technologies like IVF or not.

To participate in this trial, men must be between the ages of 18 and 50 and be part of a couple that has been trying to conceive for at least a year, or is starting their first, second, or third cycle of treatments like Intrauterine Insemination (IUI) or IVF. It's important to note that certain medical conditions or treatments may exclude individuals from participating, such as previous surgeries related to fertility or the use of donor sperm. Participants can expect to take the supplement as directed and contribute to research that could improve fertility options for men facing similar challenges.

Gender

MALE

Eligibility criteria

  • 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

About Radboud University Medical Center

Radboud University Medical Center is a leading academic medical institution located in Nijmegen, the Netherlands, dedicated to advancing healthcare through innovative research and education. As a prominent sponsor of clinical trials, Radboud UMC leverages its multidisciplinary expertise to conduct high-quality research that aims to improve patient outcomes and enhance medical knowledge. The center is committed to ethical standards and regulatory compliance, fostering collaboration among researchers, healthcare professionals, and patients to translate scientific discoveries into effective clinical applications. With a focus on personalized medicine and cutting-edge technologies, Radboud University Medical Center plays a pivotal role in shaping the future of healthcare through its rigorous clinical trial initiatives.

Locations

Eindhoven, , Netherlands

Breda, , Netherlands

'S Hertogenbosch, , Netherlands

Nijmegen, , Netherlands

Rotterdam, , Netherlands

Dordrecht, , Netherlands

Nijmegen, Gelderland, Netherlands

Voorburg, Gelderland, Netherlands

Apeldoorn, , Netherlands

Arnhem, , Netherlands

Boxmeer, , Netherlands

Doetinchem, , Netherlands

Elsendorp, , Netherlands

Leiderdorp, , Netherlands

Maastricht, , Netherlands

Roosendaal, , Netherlands

Tilburg, , Netherlands

Uden, , Netherlands

Veldhoven, , Netherlands

Wolvega, , Netherlands

Emmen, , Netherlands

Gorinchem, , Netherlands

Rotterdam, , Netherlands

Patients applied

0 patients applied

Trial Officials

Annemiek Nap, Prof.dr.

Study Director

Gynecologist, head of department of Obstetrics and Gynaecology

Annemiek Nap, Prof MD PhD

Principal Investigator

Gynecologist, head of department of Obstetrics and Gynecology

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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