Evaluate effect of of Astaxanthin, Selenomethionine, Coenzyme- Q10 & Vitamin D3 on sperm

DNA fragmentation, semen parameters in single-arm cohort study on sub-fertile male

partner with primary or secondary infertility
S. Kandari .
Cellsure Biotech & Research Centre, Andrology Division, Mumbai India.

Study question:
Study whether sperm parameters and sperm chromatin integrity
is affected post 3 month usage of empirical supplement containing
Astaxanthin, Selenomethionine, Coenzyme- Q10 & Vitamin D3 in
sub-fertile males and with any adverse outcomes
Summary answer
Significant reduction was seen on sperm DNA Fragmentation Index by 57%
and no significant differences seen in sperm motility, morphology or
concentration post 3 months of supplementation.

What is known already: Semen Impairment and DNA Damage in ejaculated spermatozoa has its source in testicular microenvironment, epididymal
transit and seminal plasma factors affecting the genetic content adversely, once the required reactive ion threshold is crossed in either of these
checkpoints. Current adjunct therapy of male sub-fertile patients is with empirical antioxidants or nutraceuticals with little consensus on the optimized
formulation. We investigated effects of nutraceutical containing Astaxanthin 8 mg+Selenomethionine 40 mcg+Coenzyme- Q10 100mg + Vitamin D3
1000 IU (Dfrag, Nutrisynapzz Therapeutix) on semen parameters and sperm DNA fragmentation post 3 to 6 months of usage.

Study design, size, duration: Participants/materials, setting, methods:

Prospective single arm cohort study was designed as single group
continuous endpoint with calculated sample size (n=48) between Feb
2017- Sep 2018; over 19 months for patients opting for over the
counter supplement. Considering loss to follow up, n = 58 patients
were recruited who partook bi-diurnal dose of one tablet and repeat
SCD and SFA was done post 3 months. Eight patients were lost to
follow up and (n=50) cohort study data was analysed.
Cohort Study Design Flow Chart :
Men aged 23- 44 years with primary or secondary infertility were analysed for
sperm DNA fragmentation index (DFI) by
sperm chromatin dispersion assay (SCD) and for concentration, motility &
morphology by semen analysis testing (SFA) by
(T IM E = 3 M O N T H S )
W.H.O laboratory manual (􀃚fth edition). Patients with >15% DFI and normal
or impaired semen parameters were included.
Subjects with endocrine disorders, autoimmune disease, secondary
antioxidants, azoospermia, testicular cancer were
excluded. Analysis of ejaculate was done according to W.H.O guideline.
T1

Study dropout
(n=9) Data QC check
Study dropout (n=8)
participants
(n=67)
V A L U E A T T 0 (T IM E = 0 ) A N D

Completed Study
(n=58)
Study
participants
analysed (n=50) Semen Parameters Values pre & post 3 months
45

40

Limitations, reasons for caution: 35

Limitations is in being a Single Arm study, using a standard DFI

30

25

threshold which is varying in di􀃙erent publications .Use of 20

42
39

Terminal deoxynucleotidyl transferase-mediated deoxyuridine 15 31.5

28.5

triphosphate-nick end labelling assay recently has been added in 10 21

follow up RCT 5
8 8 9

0
Sperm concn Morphology Motility DFI

Table 1 Semen Parameters and DNA Fragmentation Index

Main results and the role of chance: measurements at T0 and T1
The statistical power of the study is 80% with alpha = 0.01, beta =
0.2. DFI by SCD assay in sample before beginning regimen ,termed Semen Lower reference limits Average Average Mann-
period T0 and post 3 months as period T1 are statistically very Parameters (WHO 2010* / SCD Value of Value of Whitne
significant (p <0.001),by Mann-Whitney U test. DFI was lowered Assay*) patients at patients at yU
from median 21% +/- 8.63 (T0) to median 9 % +/- 2.94 (T1) post To (n=50) T1 (n=50) Test
treatment showing absolute 57% reduction in DFI. There was no
statistical difference in sperm concentration, motility or morphology Sperm 15 42 39 p=0.99
parameters, evaluated for multiple comparisons by Mann-Whitney U Concentration
Test with Bonferri-Holm correction. The difference was
Motility 32 31.5 28.5 p=1
nonsignificant in progressive sperm motility (p=1), sperm
concentration (p=1) or morphology p=1), conducted in triplicate by Morphology 4 8 8 p=1
two experienced andrologists in those two periods. The response rate DNA 15 21 9 p<0.001
of oral supplement was, in this cohort study was 100% with every Fragmentation
treated patient showing reduction in DFI but we did not observe any Index
effect on semen analysis parameters.

Wider implications of the 􀃚ndings:

Results show lower DFI at T with no reported adverse outcomes or cases of unintentional harm to patient andrological parameters. The 􀃚ndings agree
with the overall review of meta-analysis on e􀃙ect of antioxidants on sperm DNA Fragmentation as seen in a Cochrane review of Antioxidants in Male
Subfertility (2015).

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