The impact of a nutritional supplement (Impryl®) on male fertility

Recruiting

Conditions: infertility
Male subfertility
10013356

Registration Number: NL-OMON53075

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1200

Inclusion Criteria

Couples with failure to conceive for at least 12 months
Couples starting with EM or 1st/ 2nd/3rd cycle of IUI (with/without ovarian
stimulation) or IVF/ICSI
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)
Ovulation induction (OI) without IUI
IVF for an absolute tubal factor
Embryo-transfers after cryopreservation
Known chromosomal abnormalities related to infertility
Known urological abnormality such as a varicocele
Use of other vitamin supplements

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of ongoing pregnancies, conceived in the time window between<br /><br>randomization up to and including month 6 of intervention use. Ongoing<br /><br>pregnancy is defined as a visible embryonic heartbeat at ultrasound from 10-12<br /><br>weeks of gestation onwards.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are number of pregnancies conceived in the optimal<br /><br>intervention time window (i.e. between start of month 4 till the end of month<br /><br>6), overall pregnancy number, change in semen parameters between baseline and 3<br /><br>months intervention in IUI/IVF/ICSI group, based on (pre-wash) total motile<br /><br>sperm count (TMSC). Furthermore the occurrence of pregnancy, time to pregnancy,<br /><br>number of miscarriages, number of ongoing pregnancies >= 20 weeks and live birth<br /><br>rate are documented within the study period. In a population of 80 patients,<br /><br>the DNA fragmentation in sperm cells will be assessed before intake of study<br /><br>medication and after 3 months of intake of either Impryl or placebo. The<br /><br>occurrence of adverse events will be reported. </p><br>