For a CME on "RECENT ADVANCES IN CONTRACEPTIVE METHODS" in SEPT 2015 at Seth G.S.M.C & KEMH, PAREL, MUMBAI,

1. Male Contraception- Recent
Updates
DR.LOVELY JETHWANI ( MD.OBGY)
Senior Resident
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SETH G. S. MEDICAL COLLEGE AND K. E. M. HOSPITAL
Under Guidance of
DR. P. K. SHAH
PROFESSOR
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
SETH G. S. MEDICAL COLLEGE AND K. E. M. HOSPITAL
Ex-president- FOGSI, IAGE, IUFMB, MOGS, AFTT
Member- safe motherhood committee-FIGO
Member- ultrasound committee of AOFOG
Dean- Indian college of medical ultrasound

2. Male Contraception

3. • In 12 countries, the majority of men would use a
new hormonal male contraceptive
– 50% of US men
• Men are motivated by desire to share family
planning responsibility & have direct control over
their fertility
Sources:
Martin (2000) Human Reproduction 15(3): 637-45.
Heinemann (2005) Human Reproduction 20(2): 549-56.
MCC (2007) Male Contraception Quarterly 3: 1-4.
Around the world

4. Contraceptive Scenario in India
The current trends in family planning in India shows
– High level of knowledge among eligible couples
– Low acceptance remains for spacing methods.
– Female sterilization remains the most widely
used family planning method in spite of efforts to
popularize male sterilization.
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5. Key Indicators for India from NFHS-3
Family Planning
(currently married
women, age 15–49)
Current use
NFHS -1
(1992-93)
NFHS-2
(1998-99)
NFHS 3
(2005-06)
Urban Rural
Any method (%) 40.7 48.2 56.3 64.0 53.0
Any modern method (%) 36.5 42.8 48.5 55.8 45.3
Female sterilization (%) 27.4 34.1 37.3 37.8 37.1
Male sterilization (%) 3.5 1.9 1.0 1.1 1.0
IUD (%) 1.9 1.6 1.7 3.2 1.1
Pill (%) 1.2 2.1 3.1 3.8 2.8
Condom (%) 2.4 3.1 5.2 9.8 3.2
Total unmet need (%) 19.5 15.8 12.8 9.7 14.1
For spacing (%)
11.0 8.3 6.2 4.5 6.9
For limiting (%) 8.5 7.5 6.6 5.2 7.2
12/9/2015 5

6. Key Indicators for Maharashtra from NFHS-3
Family Planning
(currently married
women, age 15–49)
Current use
NFHS -1
(1992-93)
NFHS-2
(1998-99)
NFHS 3
(2005-06)
Urban Rural
Any method (%) 54.1 60.9 66.9 66.7 67.1
Any modern method (%)
52.9 59.9 64.9 64.0 65.8
Female sterilization (%)
40.3 48.5 51.1 44.2 57.5
Male sterilization (%) 6.2 3.7 2.1 1.0 3.2
IUD (%) 2.5 1.9 3.0 5.3 0.8
Pill (%) 1.4 1.7 2.4 3.6 1.3
Condom (%) 2.5 4.0 6.2 9.8 2.9
Total unmet need (%)
14.1 13.0 9.4 9.8 9.0
For spacing (%)
7.3 8.1 5.4 5.3 5.6
For limiting (%) 6.8 4.9 3.9 4.5 3.312/9/2015 6

7. 2013 Population Reference Bureau
statistics of India
Family planning methods % use
Women of 16-49 yrs ( in millions)
Total Fertility rate
Total Family planning methods
Total modern methods
Total Long acting reversible methods
Total permanent methods
Female
Male
IUCD
Injectables
Pills
Condoms
Other modern methods
Total traditional methods
Abstinence
Withdrawl
Unmet needs
323.6
2.4
54.8
48.2
1.8
36.8
--35.8
--1.1
1.8
0
3.6
5.5
0.3
6.4
-4.4
-2.0
21
FAMILY PLANNING
WORLDWIDE 2013
7
FAMILY PLANNING WORLDWIDE 2013 datasheet

8. • More recognition for the need of shared
contraceptive responsibility.
• Reduce the burden traditionally placed almost
exclusively on the female partner
• Specially in cases where female cannot adapt for
contraception due to medical or surgical
problems
Need for male contraception

9. Male contraceptive cafeteria
Contraceptive
Methods
Spacing Methods
Natural Methods
Barrier Methods
Hormonal Methods
Intra Vas
Devices
Under-trial methods
Terminal methods
sterilization(vasectomy
)
Vas
occlusion
methods

10. Natural methods
1. Abstinence
2.Coitus Interruptus: failure rate 22/HWY
Drawbacks:
• Only for educated and responsible couples
• Programmed Sex
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11. Condoms
12/9/2015 11
•Most widely used barrier
method
•Made up of fine sheath
•Most are latex
•Also available in polyurethane,
silicone, and lambskin

12. Advantages of condoms
1. Available widely without a prescription
2. Inexpensive/ free govt supply (Nirodh)
3. Latex condoms protect against STIs
4. Helpful in case of intolerance to IUCD, Oral pills or in
case of premature ejaculation
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13. Disadvantages of condoms
1. slippage/breakage during intercourse (failure
rate- 4-15%)
2. Latex allergy with latex condoms (Medical
Eligibility Criteria category 3)
3. May reduce sexual pleasure
4. Lambskin condoms do not protect against STIs
12/9/2015 13

14. More about Condoms
• Desensitizing condoms with lubricant
featuring benzocaine,helps prolong sexual
pleasure and aids in prevention of premature
ejaculation
• Spermicidally lubricated condoms (failure-1%)
• Distribution of condoms:Health worker, Asha,
Condom vending machine
12/9/2015 14

15. Terminal methods
Terminal
methods
Male
sterlisation
Vasectomy
vas occlusion
methods
12/9/2015 15

16. VASECTOMY
 A surgical procedure to resect / close the vas
deferens (the tubes that carry sperm to the penis)
 Conventional vasectomy – one or two incisions are
made in the scrotum to reach the vas deferens
 No-scalpel vasectomy – a puncture is made in the
scrotum
12/9/2015 16

17. Vasectomy- contd…
Vasectomy techniques:
• Suture ligature
• Surgical clips
• Thermal or electrocautery
• Chemical occlusion
• Vas plugs
• Vas excision
• Open-ended vas
• Fascial interposition
• Vas irrigation
12/9/2015 Vasectomy occlusion techniques for male sterilizatioN (Review) 5
Copyright © 2014 The Cochrane Collaboration. Published by JohnWiley & Sons, Ltd.
17

19. vasectomy
12/9/2015 19
NSV

20. 12/9/2015 20
VARIOUS TECHNIQUES OF VASECTOMY

21. Advantages of vasectomy
1. No routine contraceptive required
2. No interference with intercourse
3. No significant long-term side effects
4. Simple procedure
5. Less invasive and more cost-effective than tubal
ligation
6. Allows the male partner to assume some
responsibility for birth control
12/9/2015 21

22. Disadvantages of vasectomy
1. Difficult to have reversal
2. Post-sterilization regret
3. Short-term surgery-related complications:
pain and swelling; vasovagal reaction;
infection
4. No protection against STIs
5. Not effective immediately. Additional methods
required for 2.5-3 months till follow-up sperm
analysis shows no sperm
12/9/2015 22

23. Failure Rate: 0.15/HWY (due to mistaken
identification of vas)
COMPLICATIONS:
• Operative
• Sperm granules
• Spontaneous recanalisation
• Autoimmune response
• Psychological response
12/9/2015 23

24. How is NSV better than Conventional
Vasectomy
• Less time (10 min)
• Improved method of anesthesia (vas block )
has made it less painful
• Less Tissue injury, Bleeding, Hematoma
• Less infection, Fast recovery
• No incision, no stitches- Patient less nervous
12/9/2015 24

25. Vas-occlusion methods

26. R.I.S.U.G
• Reversible Inhibition of
Sperm Under Guidance
(RISUG)
• After working for almost 3
decades, Dr. Sujoy K Guha ,
IIT Kharagpur in India,has
developed RISUG
12/9/2015 26

27. RISUG
• Currently undergoing Phase III trials in India
(similar to VASALGEL under animal trials in
USA)
• FDA regulations have delayed the approval of
Vasalgel and human trials are now expected
to begin to 2015 with prospective market
release as early as 2016.
12/9/2015 27
RISUG". MaleContraceptives.org. 2011-07-27. Retrieved 2013-10-30

28. RISUG- Mechanism of action
• Non-hormonal injectable contraceptive
composed of SMA (styrene maleic anhydride)
mixed with DMSO (solvent dimethylsulfoxide)
• Partially blocks the vasa deferentia and destroys
the sperm
• Differential charge from the gel ruptures the
sperm’s cell membrane
12/9/2015 28

29. DOSE & COST
• 60 mg injection works for 10 years
• The shot itself costs less than the syringe
used to administer it, and its long term
effectiveness would make it theoretically
only a four or five time cost, in the entire
lifetime of someone who chose to continue
to be on it.
12/9/2015 29

30. • Extremely effective (>99%)
200+ men have been treated with RISUG
2 pregnancies: 1 due to improper delivery, 1 due to
marital infidelity
• Long-lasting
The first clinical trial volunteers
received RISUG in 1992; Informal
follow-up visits show they still have
effective contraception today
Sources: Guha (1993) Contraception 48(4): 367-75.
Guha (1997) Contraception 56(4): 245-50.
Impact of RISUG

31. • Transient, painless self-limiting scrotal swelling,
No granulomas like vasectomy
• No effect on the prostate gland
• Zero clinical trial attrition to date
Source: Sharma (2001) Reproduction 122(3): 431-6.
RISUG- Side Effects

32. • Reversals by multiple injection of dimethyl
sulfoxide or sodium bicarbonate – takes several
months
• Reversal proven in monkeys after 1½ years of use,
all had normal sperm count within 3 months of
reversal.
• Not yet (formally) tested in men.
Sources: Lohiya (2000) Int J of Andrology 23(1): 36-42.
Lohiya (2005) Contraception 71(3): 214-26.
How reversible is RISUG?

33. SMART RISUG
• newer version , published in 2009.
• Iron oxide and copper particles added to the
original compound, giving it magnetic properties
and the name “Smart” RISUG.
• The polymer location can be externally
controlled with magnetic field, the polymer can
change location inside the body to maximize
sterility or can be removed to restore fertility.
12/9/2015 33
Ncbi.nlm.nih.gov. 2013-03-25. Retrieved 2013-10-30.

34. SMART RISUG
• With the original RISUG polymer, the SMA can possibly clump to
neighboring proteins. With the presence of iron particles, the polymer
has lower protein binding and therefore prevents agglomeration.
• Copper particles in the compound allow the polymer to conduct heat.
When an external microwave applies heat to the polymer, it can liquify
the polymer again to be excreted to restore fertility.
• It is better choice for men who want to use RISUG as temporary birth
control Ncbi.nlm.nih.gov. 2013-03-25. Retrieved 2013-10-30.
12/9/2015 34

35. Smart RISUG
• The addition of metal ions also increases the
effectiveness of the spermicide.
• The low frequency electromagnetic field
disintegrates the sperm cell membrane in the
head region, making the sperm infertile.
• safety of Smart RISUG is still being
investigated.
12/9/2015 35
Ncbi.nlm.nih.gov. 2013-03-25. Retrieved 2013-10-30.

36. • Used in China as a
potential alternative to
vasectomy.
• Two tested types of
injectable plugs:
– Medical-grade
polyurethane (MPU)
– Medical-grade silicone
rubber (MSR).
INTRA VAS DEVICES( IVD)

37. Injectable Vas devices
• The polymer is injected directly into the vasa
deferentia and solidifies forming a flexible plug
• Less than 30 minutes under local anesthesia.
• Easier to reverse (recovery within 2 to 4 years after
the reversal procedure)
12/9/2015 37

38. • 90-100% effective
• Like vasectomy, effective after 3 months
• Sperm count required to confirm
IVD- Effectivity

39. IVD
Advantages
• Similar to no scalpel
vasectomy, but less
frequent and less severe
• No congestive epididymitis
• No spontaneous reversal
• Higher satisfaction rate
than NSV
Disadvantages
• Mild pain (10%)
• Granulomas (3%)
Source: Song (2006) Int J Andrology 29(4): 489-95.

40. Non hormonal Male pill-Gossypol
12/9/2015 40
2,2′-bis-(Formyl-1,6,7-trihydroxy-
5-isopropyl-3methylnaphthalene)
•Cotton seed derivative
•Causes azoospermia and
severe oligospermia
•Toxic(Hypokalemic Paralysis1%)
•Use for 6 months leads to
complete sterility

41. Male Hormonal Contraceptives(MHC)
• Supra-physiological dose of testosterone suppresses
testicular production of Testosterone
• Halts spermatogenesis
• May include a progestin for faster, complete suppression
• Oral formulations
• Depot injections
• Implants
• Transdermal gels and patches

42. Injectable Male Hormonal
contraceptive
12/9/2015 42
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4345754/

43. 200 mg weekly injections used in a multicentric
study (1986-1990)
• All men achieved azoospermia & were able to
sustain safe, reversible contraception for atleast 12
months (1990 WHO Task Force)
• But it required high doses of testosterone, affecting
other organs like prostate, Liver (HDL decreased) ,
Bone & Muscles
Testosterone Enanthate

44. Testosterone Buciclate(TB)
• Long Acting Testosterone ester
• Effective for 12 weeks
• Used alone or in combination with
progestrone
12/9/2015 44
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62.

45. Testosterone Undecanoate(TU)
• One of the newest & most successful
testosterone preparations
• Longer action – bimonthly or monthly
injections
• 1000 mg initial dose f/b 500mg monthly dose
were used in chinese trials found effective for
2 years
12/9/2015 45
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62.

46. Progestrone + Testosterone
Oral progestrone inhibits spermatogenesis by
inhibiting gonadotrophins and physiological
replacement of testosterone is required for
sexual functions
Levonorgestrol pill + Testosterone INJ.( Anawalt
et al 2005) was rapid & effective to inhibit
spermatogenesis but decreased HDL levels &
increased risk of coronary heart disease
12/9/2015 46
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62.

47. New Male Pill
• Less androgenic Desogestrel oral pill( 75-300ug)
along with long acting testosterone injection
which releases slowly.
• No effect on HDL levels
• Maintains male characteristics and sex drive
• 100% effective
• Completely reversible
12/9/2015 47

48. Antiandrogenic progesterone pill
• Anti androgenic progestrone cyproterone
acetate in low doses (12.5 mg daily) and
injectable testosterone 100mg per week for
16 weeks has known to cause complete
azoospermia in 8-10 weeks with no
biochemical illeffects.
12/9/2015 48
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62.

49. Implants
Recent trials with Depo
Provera 300mg 3 monthly +
Testosterone implants/
pellets 800mgs 4 monthly
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62

50. 50
Indian J Med Res. 2014 Nov; 140(Suppl 1): S58–S62.
Characteristics and results of efficacy studies with
hormonal contraceptive regimens in men

51. MHCs – Formulations
Testosterone only formulations are more effective for
Asian men

52. MHCs – Formulations
Testosterone + progestin formulations effective for all

53. • Effectivity varies by formulation and population
• Two important trials:
– WHO’s monthly im depot TU 97.7% effective in
Chinese men
– Monash Medical Center’s T pellets every 4 months +
im DMPA every 3 months 100% effective in Australian
men
MHCs – How effective are they?
Sources: Gu (2003) JCEM 88(2):562–568.
Turner (2003) JCEM 88(10):4659–4667.

54. Some men (3-10%) keep producing sperm despite
extreme suppression of FSH and LH
• Theories:
– Genetic differences in androgen regulation
– Phytoestrogens in the diet
– Insulin like GF 3 production
MHCs – “Non-responders”
Source: Amory (2007) J Andrology E-pub ahead of print.

55. • Mild weight gain, increase in lean muscle mass
• Acne
• Drop in HDL cholesterol level with some androgens ( so
desogestrol like progestrone should be used)
• Oligospermia (less than
1 million per ml) in all men
on trial
MHCs – Side effects

56. • Stop treatment, hormones begin
rebound, spermatogenesis
reinitiates
• Minimum 2½ month recovery due
to lag for production of mature
sperm
MHCs – How are they reversed?
Source: Liu (2006) The Lancet 367: 1412–20.

57. Contraceptives Under Trials

58. Adjudin “The male Patch”
Non-hormonal male
contraceptive
Non-toxic lonidamine
Analog
(2,4dichlorobenzyl-
1Hydroxy-indazole
carbohydrazide)
12/9/2015 58
Source: Mruk (2006) Nature Medicine 12(11):1323-8.

59. Adjudin- mechanism of action
• Disrupts cellular bridges between spermatids
and Sertoli cells
• Blocks the maturation of sperm in the testes
without affecting testosterone production
12/9/2015 59

60. Adjudin- contd…
• REVERSIBILTY - Normal spermatogenesis
returned in 95% within 210 days after
discontinuation
• SIDE EFFECTS - No side effects on liver and
muscles like oral effective contraceptive dose
of drug as it bypasses enterohepatic
circulation
12/9/2015 60

61. Retinoic Acid Receptor Antagonists
• Retinoic acid ( Vitamin A) – important role in sperm
production
• RAR antagonist treatment blocks sperm production
for 3 months
• 100% effective
• No observable side effects
• Fully reversible after stopping treatment
Source: Wolgemuth (2007) Future of Male Contraception abstract.

62. •Gendarussa- The Indonesian Herb!
•Male birth control pill, Gendarussa is made from the plant
Justicia gendarussa
•Research on its contraceptive properties ongoing since
1985
•The plant extract has enzymes which disrupt the ability of
the sperm to penetrate the egg, and the effect is reversible.
•Currently in Phase 4 clinical trials.
•Available only in Indonesia
Linda Bent, 2014 (Plant based methods)

63. Can Calcium channel Blocker cause
infertility in man: debatable
• Recently, the antifertility effects of
NIFEDIPENE and similar calcium channel
blockers have been detected in the chronic
hypertensive men *
• How many (%) users develop infertility … yet
to study!
12/9/2015 63
*Kanwar, Anand, & Sanyal, 1993; Kirkman-Brown, Barratt, & Publicover, 2003,
2004; Saha et al., 2000; Triggle, 2003; Yeung, Barfield, & Cooper, 2005

64. CatSper Blocker
Catsper is a gene for calcium
ion channels in various
parts of the body including
the sperm tail.
Sperm rely on calcium ions in
sperm-tail for mobility and
fertilization
In future, it can be a target for
drugs to immobilise sperms
12/9/2015 64Quill et al., 2001

65. conclusion
Family Planning Responsibilty sharing by
males can affirm our society a brighter future
with better health of the weaker sectors of
society that is mother and child.
12/9/2015 65

66. By Choice
Not by Chance

67. THANK YOU!!
Thankyou!!
12/9/2015 67