Oligospermia is a Medical problem commonly known as 'MALE INFERTILITY' and is signified by deficit in Sperm count due to which the female partner shows inability to conceive.
A new Herbal Medicine has been clinically researched & developed for treatment of OLIGOSPERMIA.
The clinical trial has been indexed by World Health Organization ( WHO) Clinical registry platform.
The research & development has been done by an Indian pharmaceutical MNC- TULIP LAB PVT. LTD.
The company has modern research center and Internationally accredited Manufacturing facility and has Pharmaceutical Products & Clinically researched Herbal Medicines/supplements.
For OUT LICENSING /CONTRACT MANUFACTURING, connect with :
Mr. VISHAL CHANDRA (GENERAL MANAGER-INTERNATIONAL BUSINESS):
* e-mail: vishalvns04@yahoo.co.in
* Skype: vishalukraine
3. Oligospermia, refers to semen with a low concentration of sperm and is a common
finding in male infertility.
Causes
Oligospermia is usually classified as*:
Mild: concentrations 10 million – 20 million sperm/ml
Moderate: concentrations 5 million – 10 million sperm/ml
Severe: concentrations less than 5 million sperm/ml
Testicular factorsPre-testicular causes
Post Testicular
factors
Pre-testicular factors refer to conditions that impede adequate support of the
testes and include situations of poor hormonal support and poor general health
including:
* Hypogonadism due to various causes * Drugs, alcohol, smoking
* Strenuous riding (bicycle riding, horseback riding)
* Medications including androgens.
Padubidri; Daftary (2011). Shaw's Textbook of Gynaecology, 15e. p. 204. ISBN 9788131225486
4. Oligospermia
Testicular factorsPre-testicular causes
Post Testicular
factors
Testicular factors refer to conditions
where the testes produces semen of
poor quality despite adequate
hormonal support and include:
* Age
* Genetic defects on the Y chromosome
or Abnormal set of chromosomes
* Klinefelter syndrome
* Neoplasm e.g. seminoma
* Cryptorchidism * Varicocele
* Trauma * Hydrocele * Mumps
* Malaria
Post-testicular factors decrease
male fertility due to conditions that
affect the male genital system after
testicular sperm production and
include defects of the genital tract
as well as problems in ejaculation:
* Vas deferens obstruction
* Lack of Vas deferens, often
related to genetic markers for
Cystic Fibrosis
* Infection, e.g. prostatitis.
* Ejaculatory duct obstruction
5. Treatment options of male infertility
The basic approach towards management of male infertility includes confirmation of diagnosis ,
cause and correctable conditions.
If correctable condition is not present the management ( Pharmacological/mechanical) is
dependent on making optimal use of sperms that are available.
Medical Management
• Clomephene
• Gonadotrophins
• Bromocriptine
• L-Thyroxine
• Vit E etc.
Mechanical
Management
• Intra Uterine
Insemination
• In Vitro Fertilization
• Intra cytoplasmic
Sperm Injections
6. Treatment options of male infertility
The basic approach towards management of male infertility includes confirmation of diagnosis ,
cause and correctable conditions.
If correctable condition is not present the management ( Pharmacological/mechanical) is
dependent on making optimal use of sperms that are available.
Limitations:
• Effectiveness
• Risk of infection
• Multiple pregnancies
• Complications
• Cost
11. Asparagus racemosus , Chlorophytum borivilianum
A significant effect on the sperm count, seminal fructose content and penile erection
index was observed upon treatment with the extracts.
The effect of extracts on inducible NO release in vitro directly correlated with the
enhanced erectile function in vivo.
Volume 43, Issue 4, pages 273–277, August 2011: Improvement of penile erection, sperm count and seminal fructose levels in vivo and nitric
oxide release in vitro by ayurvedic herbs
Ingredient wise profile
Inhibitory effect on pro-inflammatory cytokines: interleukin 1β and
tumour necrosis factor α
Production of nitric oxide in macrophage cells.
Inhibition in the production of interleukin 2.
Optimization of Corticosterone levels in serum and adrenal glands.
Beneficial in the management of stress and inflammatory conditions.
Phytotherapy Research:Volume 24, Issue 10, pages 1562–1566, October 2010
12. Causes bioremediation in biochemical and histological parameters and
restores normal sperm count:
Restoration in primary and secondary spermatocyte.
Stimulates seminiferous tubules.
Restoration of Lumen.
Potent Antioxidant Protection.
Significant antistress adaptogenic activity:
Augment resistance of the body against disease and diverse adverse
environmental factors, revitalise the body in debilitated conditions
and increase longevity.
Withania somnifera
* Global Journal of Traditional Medicinal Systems; Vol 1, No 1 (2012): Kumar
* Pharmacology Biochemistry and Behavior :Volume 75, Issue 3, June 2003, Pages 547–555
13. Stimulates sex hormones due to the presence of protodioscin.
Increases testosterone by inhibition of Testicular tissue peroxidation.
Improves di-hydroxytestosterone levels.
Improves levels of dehydroepiandrosterone sulphate (DHEA
Hormone)in the epedidymis.
Possesses Androgen increasing property.
* Phytomedicine :Volume 15, Issues 1–2, 25 January 2008, Pages 44–54
Tribulus terrestris
14. This Extract is rich in isoflavonoids particularly puerarin, genistein and
daidzein, which are individually & collectively responsible for the
therapeutic potential against a wide range of ailments.
Restorative tonic, antiaging, spermatogenic and immune booster
activity.
Improves Androgenesis and Sexual Behavior via FSH LH Cascade
Positive effect on gonadotropin release hormone GnRH.
Shows significant androgenic stimulation of epididymis and seminal
vesicles leading to better Spermatogenesis and increased sexual
behaviour.
*Natural Product Research: Formerly Natural Product Letters Volume 28, Issue 23, 2014
*Pueraria tuberosa DC Extract Improves Androgenesis and Sexual Behavior via FSH LH Cascade: The Scientific World Journal
Volume 2013 (2013), Article ID 780659
Pueraria tuberosa
15.
16. Scientifically Developed * Clinically Tested
Placebo Controlled Trials in Human Beings
Toxicology Studies
• Acute Toxicity Studies on ‘Spertinex have been
done’ as per OECD guidelines.
• 90 Days Chronic Toxicity studies have also been
successfully conducted as per OECD guidelines
Spertinex
Capsules
17. Group of patients:
- Males between age group22 to 45
years, with minimum 1 year regular
unprotected sexual life but their
partners unable to conceive were
shortlisted.
- Patients with Sperm Count less than
15 million/ ml*,with normal Sperm
morphology and with motility at
least 40% were shortlisted.
Распределение по группам
Group A
(Placebo)
Group B
(Spertinex)
Total No. of patients 25 24
No. of patients with
incomplete
Trial/Discontinuation of
treatment
02 02
Patients that completed
Trial
23 22
* As per WHO laboratory manual for the examination and processing of human semen, Fifth Edition, 2010)
A Randomised , double blind, placebo Controlled, multi centre,
parallel group Clinical trial to see safety & efficacy of ‘Spertinex’
in patients with low sperm count (Male infertility- Oligo spermia)
18. Primary Outcome Time points
Changes in total sperm count Screening visit (Day -7), Day 0, Day 90 and Day 120
Secondary Outcome Time points
Screening visit (Day -7), Day 0, Day 90 and Day 120
1. Changes in semen volume, Sperm motility with progressive sperm motility,
total number of spermatozoa per ejaculate, Sperm Morphology, viability of
spermatozoa, serum levels of total and free testosterone, serum level of
prolactin, LH and FSH,
2. Changes in the number of spontaneous achieved pregnancies.
3. Global assessment for overall improvement by the patient and by the Investigator
4. Tolerability of study drugs
5. Changes in Laboratory parameters
A Randomised , double blind, placebo Controlled, multi centre,
parallel group Clinical trial to see safety & efficacy of ‘Spertinex’
in patients with low sperm count (Male infertility- Oligo spermia)
19. Result at the end of Clinical Study:
At the End of treatment mean sperm Concentration showed 1.3
times significant rise among SPERTINEX group.
At the End of treatment mean semen volume showed fall of 10.1%
among Placebo Group where as 0.5% rise among SPERTINEX Group
from baseline .
At the End of treatment mean progressive motility showed
insignificant rise of 28.8% among Group A whereas 73.2% significant
rise among SPERTINEX Group.
At the end of treatment , Mean Total Sperm Count in SPERTINEX
Group increased by 1.7 times which was significant from baseline.
Safe & Natural Formula High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
20. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
COMPARISON OF CHANGES IN MEAN SPERM CONCENTRATION
AFTER TREATMENT BETWEEN TWO GROUPS
10.07
14.58
11.17
8.19
17.97
18.50
0
2
4
6
8
10
12
14
16
18
20
Baseline 90 120
DURATION IN DAYS
MEANSPERMCONCENTRATION(million/ml)
Group A
Group B
Spertinex
Placebo
Spertinex showed 1.3 times increase in Sperm concentration.
21. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
COMPARISON OF CHANGES IN MEAN TOTAL MOTILITY
AFTER TREATMENT BETWEEN TWO GROUPS
43.13
54.17
43.75
36.65
45.00
34.55
0
10
20
30
40
50
60
70
80
Baseline 90 120
DURATION IN DAYS
MEANTOTALMOTILITY(%)
Group A
Group B
Spertinex
Placebo
56.8% significant rise among Spertinex Group
22. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
COMPARISON OF CHANGES IN MEAN TOTAL SPERM NUMBER
AFTER TREATMENT BETWEEN TWO GROUPS
15.28
17.55
16.05
10.47
26.46
28.10
0
5
10
15
20
25
30
35
40
Baseline 90 120
DURATION IN DAYS
MEANTOTALSPERMNUMBER(million/ml)
Group A
Group B
Spertinex
Placebo
Significant Increase of 1.7 times from baseline in SPERTINEX group.
23. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
COMPARISON OF CHANGES IN MEAN PROGRESSIVE MOTILITY AFTER
TREATMENT BETWEEN TWO GROUPS
15.53
22.33
20.00
21.74
27.37
37.65
0
10
20
30
40
50
60
Baseline 90 120
DURATION IN DAYS
MEANPROGRESSIVEMOTILITY(%)
Group
A
Group
B
Spertinex
Placebo
73.2% significant rise among SPERTINEX Group
24. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
505.15
425.76
421.03
472.83
0
50
100
150
200
250
300
350
400
450
500
550
MEANSERUMTOTALTESTOSTERONE
Baseline 120
DURATION IN DAYS
COMPARISON OF CHANGES IN MEAN SERUM TOTAL TESTOSTERONE AFTER
TREATMENT BETWEEN TWO GROUPS
Group A
Group B
Spertinex
Placebo
In Placebo Group a downfall of 15.7% was
observed ,whereas a 4.5 % Increase was
observed in SPERTINEX group
25. Safe & Natural Formula
High level of patient
Satisfaction
Effectively improves Quality of
Sperms
SPERTINEX
13.0
8.7
13.0
65.3
63.7
31.8
4.5
0
10
20
30
40
50
60
70
80
90
100
PROPORTIONOFCASES
Group A Group B
GROUPS
PATIENT’S GLOBAL EVALUATION FOR OVERALL IMPROVEMENT
Poor
Fair
Good
Excellent
• 63.7% Excellent improvement after the
treatment in SPERTINEX Group.
• 31.8% showed Good Improvement .
• 4.5% showed Poor Improvement.
26. Spertinex…Spurts up the count
Spertinex Stimulates the
process of formation of sperms
in ‘Seminiferous tubules’ of the
testes and increases
concentration of sperms in
semen.
Spertinex corrects
abnormalities of the semen
and makes semen more
competent and viable for
successful conception.
Spertinex helps to stimulate
secretion of androgens and
enhances the production of
sperms.
Spertinex reduces Stress,
Performance Anxiety,
depression in males and
thus ensures production
of healthy and viable
sperms.
Spertinex improves libido
and sexual performance
of males.
Spertinex provides
antioxidant protection
and rejuvenates the body.
28. Treatment with ‘Spertinex’ did not show any significant
change in laboratory investigations like Haemogram, Lipid
profile, Liver Function Test, Renal profile, Urine
investigations, Diabetic Profile.
Treatment with ‘Spertinex did not show any significant
change in normal pattern of sleep, appetite, bowel
evacuation, pulse rate, body temperature, blood pressure,
respiratory rate etc.
Evaluation of Laboratory & Physiological Parameters
29. COMPARISON OF CHANGES IN MEAN VITALITY
AFTER TREATMENT BETWEEN TWO GROUPS
34.50
46.00 44.55
50.71
52.73
59.38
0
10
20
30
40
50
60
70
Baseline 90 120
DURATION IN DAYS
MEANVITALITY(%)
Group A
Group B
At the End of treatment mean vitality showed 17.1% increase in
Spertinex Group
31. This study confirms the beneficial effect of ‘Spertinex’ on Male Infertility.
Treatment with ‘Spertinex’ significantly increased (p < 0.05) the Total sperm count by 1.3
times and total sperm number by 1.7 times .
Summary
32. Treatment with ‘Spertinex’ significantly increased the total sperm
motility by 56.8% and progressive sperm motility by 73.2%
33. Treatment with ‘Spertinex’ showed excellent overall improvement in
63.7% of the study cases and Good improvement in 31.8% of the study
cases as per the evaluation by Investigators & Subjects.
Excellent
Good
Fair
Poor
34. This study confirms safety of ‘Spertinex’ in treatment of Male Infertility.
Treatment with ‘Spertinex’ had excellent tolerability by 100.0%
of the cases as per the evaluation by the subject and by the investigator
Spertinex showed No changes in Laboratory & Physiological Parameters
Treatment with ‘Spertinex’ showed minute increase in semen volume, Sperm
Morphology and vitality of spermatozoa.
Mean Serum Total Testosterone and FSH also showed an increasing tendency.
Whereas Insignificant fall in mean Serum Free Testosterone, serum level of LH
(Luteinizing Hormone) was seen in Spertinex group
35. Help maturation of spermatozoa & motility of sperm.
Probable
factors for
Successful
results
Help in regeneration of
seminiferous
tubules.
Possess testosterone
like effect on
seminiferous tubules
that enhances
spermatogenesis.
Stimulate testosterone
production from Leydig
cells to improve
Improve DHEA level
in epididymis
High quality ‘STANDARDIZED EXTRACTS’
36. Anti-oxidant action of ingredients reduce free radical induced
damage and oxidative stress.
In seminal plasma, Inhibition of testicular tissue peroxidation in
seminal plasma protects sperms from ROS mediated damage.
Most of the ingredients have potent sexual stimulant action due to
androgen increasing property thus increase sexual desire.
Anxiolytic, antidepressant and adaptogenic property of the
ingredients help to reduce depression, stress & performance anxiety.
Almost all ingredients nourish & vitalize the male sexual organs thus
increase the overall sexual performance.
Natural synergy of standardized extracts … Assured Results
Success , When it matters for
“YOU & HER”
37. SPERTINEX
Capsules
Ingredients Quantity in each capsule
Chlorophytum arundinaceum 110 mg
Asparagus racemosus 105 mg
Withania Somnifera 100 mg
Tribulus terrestris 90 mg
Purera tuberose 75 mg
Consider SPERTINEX For treatment of :
• Low sperm count
- Oligospermia, Asthinozoospermia, Tettazoospermia, Oligozoospermia
• Decreased Libido
Treatment Regimen-4 months is expected to:
• Normalize Spermatogenesis
• Improve Fertility – Increase in Sperm Count &
Concentration of Sperms.
• Improves Quality of Sperms .
38. Do not believe in the figures and charts…. Try SPERTINEX in your next patient !
Spertinex…Spurts up the count !