controlled study varicocele study pilot study...lenus pharma gesmbh seeböckgasse 59, 1160...

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www.profertil.eu CONTROLLED STUDY VARICOCELE STUDY PILOT STUDY IMPROVING MALE FERTILITY

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Page 1: controlled study varicocele study pilot study...Lenus Pharma GesmbH Seeböckgasse 59, 1160 Vienna/Austria Phone: +43 1 405 14 19,Fax: +43 1 405 14 19-20 profertil@lenuspharma.com,

www.profertil.eu

controlled studyvaricocele studypilot studyimproving male fertility

Page 2: controlled study varicocele study pilot study...Lenus Pharma GesmbH Seeböckgasse 59, 1160 Vienna/Austria Phone: +43 1 405 14 19,Fax: +43 1 405 14 19-20 profertil@lenuspharma.com,

the European e-Journal of Clinical Nutrition & Metabolism 12/2011

Controlled Study 2011

“ Micronutrient supplementation increases sperm quality in the subfertile male.”

m. imhof, J. lackner, m. lipovac, p. chedraui

and c. riedl

in the context of this controlled com-parative study an active treatment group was invited to take two cap-sules of profertil® daily for a period of 3 month between the first and the follow up semen analysis. subfertile men receiving no active treatment served as controls.

all parameters evaluated by semen analysis significantly increased after 3 months of treatment:

25.76% pregnancies

in the treatment group after six months

& no adverse effects

treatment control group group

patients (205) 132 73inclusion ≥1yearofsubfertility criteria and≥2semenanalysisexclusion Azoospermia,aspermia,varico- criteria cele,recenturogenitalinfections

improvement in % after 3 months

ejaculatory volume (ml) + 33.3% + 3.7%sperm cell density (mill/ml) + 215.5% + 46.4%progressive motility (%) + 83.1% + 44.0%normal morphology (%) +23.0% -2.4%total motility (%) + 36.4% + 33.9%

n_0 n_3

4

8

12

16

20Sperm Cell Density (mill/ml)

˙

n_0 n_3

35

40

30

45

50

55Progressive Motility (%)

˙

n_0 n_3

3.1

2.7

2.3

2.0

3.5Ejaculatory Volume (ml)

n_0 n_3

25

30

35

40

45Normal Morphology (%)

˙

˙WHO Lower Limits 1998 Treatment Group Control Group

Page 3: controlled study varicocele study pilot study...Lenus Pharma GesmbH Seeböckgasse 59, 1160 Vienna/Austria Phone: +43 1 405 14 19,Fax: +43 1 405 14 19-20 profertil@lenuspharma.com,

Varicocele Study 2009

“ Micronutrients as an alternative to fertility treatment in men with subclinical varicocele “1)

1) Source: Fortbildungstagung der österr. Gesellschaft für Urologie und Andrologie mit Jahreshauptversamm-lung der ÖGU Linz, Austria 2010; EAU Bratislava 2010

treatment group

patients (51) 51,ø32years(18–43)inclusion Infertility>2years criteria Atleast2pathological semenanalysisexclusion Infections,aspermia, criteria hormonaldisturbances

improvement in % after 3 months

ejaculatory volume (ml) + 15.57%sperm cell density (mill/ml) + 11.88%progressive motility (%) + 43.72%normal morphology (%) + 18.22%total motility (%) + 15.99%

i. schauer, r. Jost, m. imhof

in the context of this study 51 men with subclinical varico- cele (Who classification 0.1), two pathological spermiogrames and an unfulfilled desire for a child took 2 capsules of profertil® daily for the duration of 3 months.

after a time period of 3 months a new semen analysis was performed.

41.18% pregnancies in the treatment group after six months & no adverse effects

2 3 4 5

Ejaculatory Volume (ml)

Sperm Cell Density (mill/ml)

3020 40 50 7060

Progressive Motility (%)

105 15 20

Normal Morphology (%)

22 2624 28 30

WHO Lower Limits 1998

˙

Page 4: controlled study varicocele study pilot study...Lenus Pharma GesmbH Seeböckgasse 59, 1160 Vienna/Austria Phone: +43 1 405 14 19,Fax: +43 1 405 14 19-20 profertil@lenuspharma.com,

Lenus Pharma GesmbH Seeböckgasse59,1160Vienna/Austria Phone:+4314051419,Fax:+4314051419-20 [email protected],www.lenuspharma.com

Pilot Study 2006–2008

“ The use of the nutraceutical PROfertil® – a therapy of the male factor”2)

2) Source EAU Bratislava 2010

treatment group

patients (120) 120,ø35,9years(23–58)inclusion Infertility>2years criteria Atleast2pathological semenanalysisexclusion Varicocele,infections,aspermia, criteria hormonaldisturbances

improvement in % after 3 months

ejaculatory volume (ml) + 24.05%sperm cell density (mill/ml) + 80.54%progressive motility (%) + 115.30%normal morphology (%) + 24.91%total motility (%) + 48.71%

m. imhof

the goal of this study was to admi-nister a combination product com-prising 8 substances, which are all known to improve semen quality. the hypothesis is that the effect of the single substances accumulate and therefore ensure a stronger response.

the patients took 2 capsules of profertil® a day for the duration of 3 months.

17.5% pregnancies

in the treatment groupafter six months

& no adverse effects

2 3 4 5

Ejaculatory Volume (ml)

Sperm Cell Density (mill/ml)

2010 30 40 6050

Progressive Motility (%)

105 15 20

Normal Morphology (%)

30 35 40

WHO Lower Limits 1998

˙