Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Radboud University Medical Center

Collaborating Sponsors:

Goodlife Fertility B.V.

Conditions:

Male Subfertility

Eligibility:

MALE

18-50 years

Phase:

NA

Brief 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 infert...

Detailed 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. ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 23 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2026

Estimated Enrollment :

1200 Patients enrolled

Trial Details

Trial ID

NCT03337360

Start Date

April 23 2018

End Date

April 30 2026

Last Update

April 4 2025

Active Locations (21)

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Page 1 of 6 (21 locations)

1

Fertiliteitscentrum Voorburg

Voorburg, Gelderland, Netherlands

2

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands, 5200ME

3

Gelre Ziekenhuizen

Apeldoorn, Netherlands, 7334DZ

4

Rijnstate

Arnhem, Netherlands, 6815AD