Infertility, Male
Conditions
Keywords
male infertility, spermatogenesis, antioxidants, DNA damage, mitochondrial membrane potential, apoptosis
Brief summary
The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures.
Detailed description
In the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (ISCI) will be included. In the double blind study male patients will be given astaxanthin with vitamin E (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to ART. In the study and the control group the quality of sperm (spermiogram), DNA fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. In the ART procedure (ICSI) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group.
Interventions
DIETARY_SUPPLEMENTastaxanthin with vitamin E
Four tablets of 4 mg astaxanthin with 10 mg vitamin E daily, taken at once. Daily dose is 16 mg astaxanthin with 40 mg vitamin E. Continuously for three months.
OTHERPlacebo
Four tablets of placebo daily, taken at once. Continuously for three months.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
no other masking
Intervention model description
Eighty infertile men with OAT were randomly assigned to receive either daily 16 mg of astaxanthin and 40 mg of vitamin E in capsules or placebo. At baseline and after three months of treatment semen quality was assessed according to the WHO guidelines. The sperm concentration, motility and morphology were determined by standard microscopic analyses. Sperm DNA fragmentation was evaluated using a TUNEL assay . Mitochondrial membrane potential was measured by means of 3,3'-dihexyloxacarbocyanine iodide (DiOC6) staining as an indicator of mitochondrial membrane integrity and the mitochondrial potential capacity to generate ATP by oxidative phosphorylation. The serum level of FSH was measured by a solid-phase, two-site chemiluminescent immunometric assay.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* oligoasthenozoospermia with of without teratozoospermia by WHO criteria from the year 2010 * fresh semen * female partner younger than 38 years * idiopathic or tubal infertility in female partners * at least 4 oocytes retrieved in previous ovarian punction in ART cycle, if previously performed * 1st, 2nd or 3rd cycle of ART
Exclusion criteria
* genetic indication for ART procedure * donated semen * polycystic ovary syndrome in female partner * dietary supplementation intake of antioxidants (selenium, zink, vitamin E, vitamin C, vitamin A) in male participant in the last three months * smoking in male participant \>20 cigarettes per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| semen quality | three months | In semen quality the spermiogram, DNA fragmentation and mitochondrial membrane potential before and after the intervention will be evaluated. The DNA fragmentation will be evaluated by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate (dUTP)-biotin nick end labeling (TUNEL) method, and mitochondrial membrane potential with carbocyanine fluorochrome DiOC6. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| follicle stimulating hormone (FSH) | three months | FSH levels in before and after the intervention will be evaluated in infertile men with oligoasthenozoospermia. |
| fertilization and embryo development in Assisted Reproduction Techniques (ART) | six months | Fertilization rates and the quality of embryo development on day 3 in ICSI procedure in infertile couples will be determined after the three months of dietary supplementation of astaxanthin with vitamin E taken by infertile men with oligoasthenozoospermia. |
| pregnancy rates and miscarriage rates in 1st trimester after ART | nine months | Pregnancy rates and miscarriage rates in 1st trimester after ART will be determined after the three months of dietary supplementation of astaxanthin with vitamin E taken by infertile men with oligoasthenozoospermia. |
Countries
Slovenia
Outcome results
None listed