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humans. As India's population grew throughout the 1970s, Guha modified his heart pump design to create a water pump that could work off of differences in ionic charges between salt water and fresh water in water treatment facilities. This filtration system did not require electricity and could potentially help large groups of people have access to clean water. India, however, decided that the population problem would be better served by developing more effective contraception. So Guha again modified his design to work safely inside the body, specifically inside the male genitalia. The non-toxic polymer of RISUG also uses differences in the charges of the
295:
than there are for women, or they may fear the side effects, or it may conflict with their cultural or religious beliefs. However, the same study published that in the year 2000, an international survey found that 83% of men were willing to use a male contraceptive. Despite this, pharmaceutical companies are reluctant to lose market share of a thriving global market for female contraceptives and condoms which bring billions of dollars of revenue each year. Initially, RISUG attracted some interest from pharmaceutical companies. However, considering that RISUG is an inexpensive, one-time procedure, manufacturers retracted.
28:
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fertility. Smart RISUG is therefore a better choice for men who want to use RISUG as temporary birth control, since it does not require a second surgery to restore fertility. 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. This in turn causes both
287:, the average time taken for a drug to go from concept to market is 10 to 15 years, whereas, it has been over four decades since Guha published his original paper on RISUG. RISUG aims to provide males with years-long fertility control, thereby overcoming compliance problems and avoiding ongoing costs associated with condoms and the female
279:
had successfully completed clinical trials of the world's first injectable male contraceptive, which was then sent to the Drug
Controller General of India (DCGI) for regulatory approval. The trials were over, including extended, phase III clinical trials, for which 303 candidates were recruited with
234:
of clinical trials on the basis of presence of styrene and maleic anhydride in the formulation. In response, Guha argued that substances can be individually toxic in nature but harmless as compounds like pure chlorine, which can melt human flesh on its own, but, when combined with sodium, it becomes
319:
With the presence of iron particles, the polymer has lower protein binding and therefore prevents agglomeration. The 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
303:
Smart RISUG is a newer version of the male contraception that was published in 2009. The polymer adds iron oxide and copper particles to the original compound, giving it magnetic properties and the name "Smart RISUG". After injection the exact location of the polymer inside the vas deferens can be
294:
Pharmaceutical companies have expressed little interest in RISUG. One obstacle facing marketing of the product is that men generally perceive contraception as a woman's issue. Men may choose not to use alternative methods of contraception because there are fewer options for birth control for them
106:
developed RISUG after years of developing other inventions. He originally wanted to create an artificial heart that could pump blood using a strong electrical pulse. Using the 13-chamber model of a cockroach heart, he designed a softer pumping mechanism that would theoretically be safe to use in
266:
and Indian researchers say that the studies were not done according to recent international standards. Due to the lack of any evidence for adverse effects, trials were restarted in 2011. Guha says concerns over the safety and efficacy of the drug have mainly come from the NIH and WHO.
188:
for every 40 g of copolymer and a dose rate of 30 to 40 rad/s. Dr
Pradeep K. Jha, a senior scientist, worked on the effects of gamma dose rate and total dose interrelation on molecular designing and biological function of polymer. The source of irradiation is
312:. The polymer location can also be externally controlled using a pulsed magnetic field. With this magnetic field, the polymer can change location inside the body to maximize sterility or can be removed to restore fertility. The polymer has
559:
Jha, Pradeep K.; Jha, Rakhi; Gupta, B.L.; Guha, Sujoy K. (May 2010). "Effect of γ-dose rate and total dose interrelation on the polymeric hydrogel: A novel injectable male contraceptive".
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The safety of Smart RISUG is uncertain and requires additional research. The spermicidal properties of the compound should not have negative effects on the lining of the vas deferens.
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Sharma, RadheyShyam; Mathur, AjitKumar; Singh, Rajeev; Das, HemChandra; Singh, GulshanJeet; Toor, DevinderPal Singh; Guha, SujoyKumar (2019).
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rats used to develop the new polymer did not have any adverse symptoms. The original compound had been tested for over 25 years in rats.
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that allows it to stretch and elongate to better line the vas deferens. The iron oxide component is necessary to prevent agglomeration.
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and the clinical trials did not resume by 1996, he went to the
Supreme court and the next round of clinical trials resumed afterwards.
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919:"Safety & efficacy of an intravasal, one-time injectable & non-hormonal male contraceptive (RISUG): A clinical experience"
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87:, who were unable to bring the product to market over the next decade. In 2023, the patent for Vasalgel was acquired by
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The effect the chemical has on sperm is not completely understood. Originally, researchers thought it lowered the
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133:, which has branded it as "Vasalgel". Vasalgel, which has a slightly different formulation than RISUG, underwent
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mosaic. Within an hour after placement the differential charge from the gel will rupture the sperm's
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RISUG works by an injection into the vas deferens, the vessel through which the sperm moves before
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790:"Smart RISUG: A potential new contraceptive and its magnetic field-mediated sperm interaction"
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sodium chloride – the basic salt that people consume in their diets. When it did not persuade
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Khilwani, Barkha; Badar, Ayesha; Ansari, Abdul S.; Lohiya, Nirmal K. (December 2020).
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Diagram showing the site of injection of the product
Vasalgel, a vasectomy alternative
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clinical trials were underway in India, and were slowed by insufficient volunteers.
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as it passes through the vas, deactivating it before it can exit from the body.
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rights to RISUG in the United States were acquired between 2010 and 2012 by the
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Lohiya, N.K.; Alam, I.; Hussain, M.; Khan, S.R.; Ansari, A.S. (November 2014).
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RISUG has been patented in India, China, Bangladesh, and the United States.
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638:"The Professor Who Had to Spend Half His Life to Make the Drug India Needs"
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coats the walls of the vasa with a clear gel made of 60 mg of the
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in that a local anesthetic is administered, an incision is made in the
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Guha theorizes that the polymer surface has a negative and positive
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739:"RISUG® as a male contraceptive: journey from bench to bedside"
91:, which plans to bring the technology to market under the name
357:"Poor response from male volunteers hits RISUG clinical trial"
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enzymes to leak out of the sperm, making the sperm infertile.
662:
Indian
Ministry of Health & Family Welfare (2002-10-11).
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in the United States, but reversibility proved unsuccessful.
694:"India closer to world's first male contraceptive injection"
262:
has reviewed and approved the toxicology data three times,
200:
79:
Beginning in 2011, a contraceptive product based on RISUG,
230:
testing in clinical trials had been questioned after
884:"RISUG: An intravasal injectable male contraceptive"
788:
Jha, Rakhi K; Jha, Pradeep K; Guha, Sujoy K (2009).
419:"'Plan A' Offers a New Option in Male Birth Control"
394:"The Revolutionary New Birth Control Method for Men"
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246:aborted the clinical trials due to reports of
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203:of the environment enough to kill the sperm.
36:Reversible inhibition of sperm under guidance
8:
715:"A New Kind of Male Birth Control Is Coming"
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1018:Preventing sexually-transmitted infections
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535:"Expanding Options for Male Contraception"
510:The Oxford Handbook of Reproductive Ethics
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83:, was under development in the US by the
42:), formerly referred to as the synthetic
513:. Oxford University Press. p. 336.
482:. Parsemusfoundation.org. Archived from
539:Planned Parenthood Advocates of Arizona
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385:
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888:The Indian Journal of Medical Research
1411:Experimental methods of birth control
794:International Journal of Nanomedicine
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1023:Over-the-counter oral contraceptives
614:. MaleContraceptives.org. 2011-07-27
1008:Comparison of birth control methods
1385:Male contraceptives in development
923:Indian Journal of Medical Research
692:Kaul, Rhythma (19 November 2019).
25:
713:Altstedter, Ari (29 March 2017).
581:10.1016/j.radphyschem.2009.11.010
439:. April 14, 2008. Archived from
53:), is the development name of a
1028:Oral contraceptive formulations
674:from the original on 2023-06-04
561:Radiation Physics and Chemistry
1:
417:Hobbins, Katie (2023-08-22).
355:Jyoti, Archana (2011-01-03).
291:, which must be taken daily.
743:Basic and Clinical Andrology
456:"'Honey, It's Your Turn...'"
454:Beck, Melinda (2011-06-14).
433:"An Indian artificial heart"
392:Gifford, Bill (2011-04-26).
176:. The copolymer is made by
1335:Fertility awareness methods
365:. New Delhi. Archived from
304:measured and visualized by
258:participants. Although the
184:with a dose of 0.2 to 0.24
131:not-for-profit organization
1437:
310:magnetic resonance imaging
271:Availability and marketing
244:India's Ministry of Health
1330:Calendar (rhythm) methods
756:10.1186/s12610-020-0099-1
936:10.4103/ijmr.IJMR_635_18
507:Francis, Leslie (2017).
254:and scrotal swelling in
166:styrene/maleic anhydride
115:as it flows through the
47:styrene maleic anhydride
1416:Contraception for males
1406:Male genital procedures
1245:Emergency Contraception
870:ICMR 2004 Annual Report
598:March 17, 2005, at the
460:The Wall Street Journal
314:magnetoelastic behavior
57:injection developed at
1421:Biological engineering
1165:Multi-month injections
1108:Hormonal contraception
1072:Levonorgestrel implant
1038:Long-acting reversible
275:By November 2019, the
149:. RISUG is similar to
32:
1293:Vaginal pH modulation
1270:Low-dose mifepristone
1170:Progestogen-only pill
1064:Contraceptive implant
852:U.S. patent 5,488,075
480:"Parsemus Foundation"
421:. www.mddionline.com.
123:Intellectual property
30:
1325:Breastfeeding method
1235:Contraceptive sponge
1119:estrogen–progestogen
1068:Etonogestrel implant
894:(Suppl 1): S63–S72.
664:"PIB Press Releases"
222:The thoroughness of
1360:Non-penetrative sex
1352:vaginal intercourse
1317:vaginal intercourse
1137:Contraceptive patch
1132:Extended cycle Pill
1049:Intrauterine device
1013:Male contraceptives
573:2010RaPC...79..663J
127:Parsemus Foundation
85:Parsemus Foundation
65:by the team of Dr.
1260:Ulipristal acetate
1248:(Post-intercourse)
1142:Monthly injections
875:2012-04-15 at the
863:2013-03-08 at the
668:archive.pib.gov.in
289:birth control pill
174:dimethyl sulfoxide
89:NEXT Life Sciences
55:male contraceptive
33:
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807:10.2147/ijn.s4818
520:978-0-19-998187-8
443:on July 22, 2009.
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1378:Experimental
1225:Cervical cap
1193:Ormeloxifene
1175:Vaginal ring
1147:Vaginal ring
1053:Hormonal IUD
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80:
78:
71:
50:
39:
35:
34:
1298:Nonoxynol-9
1285:Spermicides
362:The Pioneer
299:Smart RISUG
180:of the two
178:irradiation
147:ejaculation
99:Development
1400:Categories
1365:Abstinence
1340:Withdrawal
1307:Behavioral
1255:Copper IUD
1058:Copper IUD
678:2023-10-31
648:2020-10-19
618:2013-10-30
545:2012-03-28
490:2012-10-13
465:2012-10-13
403:2020-10-19
373:2011-06-08
339:References
141:Mechanisms
1314:Including
1230:Diaphragm
1127:Oral pill
1097:Vasectomy
816:1176-9114
800:: 55–64.
719:Bloomberg
191:cobalt-60
163:copolymer
159:injection
151:vasectomy
74:Phase III
1349:Avoiding
1117:Combined
1093:(female)
955:31571633
910:25673546
873:Archived
861:Archived
834:19421370
775:32082579
749:(1): 2.
672:Archived
642:The Wire
596:Archived
228:toxicity
182:monomers
81:Vasalgel
995:methods
946:6798614
901:4345756
825:2720737
766:7017607
612:"RISUG"
569:Bibcode
322:acrosin
283:In the
248:albumin
232:phase I
186:megarad
155:scrotum
44:polymer
1099:(male)
1042:(LARC)
953:
943:
908:
898:
832:
822:
814:
773:
763:
517:
333:Albino
218:Safety
1185:SERMs
398:Wired
306:X-ray
252:urine
113:sperm
109:semen
63:India
40:RISUG
18:RISUG
951:PMID
906:PMID
830:PMID
812:ISSN
771:PMID
515:ISBN
324:and
308:and
277:ICMR
260:ICMR
237:ICMR
226:and
129:, a
941:PMC
931:doi
927:150
896:PMC
892:140
820:PMC
802:doi
761:PMC
751:doi
577:doi
264:WHO
250:in
61:in
51:SMA
1402::
1070:,
949:.
939:.
925:.
921:.
904:.
890:.
886:.
828:.
818:.
810:.
796:.
792:.
769:.
759:.
747:30
745:.
741:.
727:^
717:.
696:.
670:.
666:.
640:.
627:^
575:.
565:79
563:.
537:.
499:^
458:.
435:.
396:.
382:^
359:.
347:^
201:pH
196:.
170:μL
119:.
95:.
69:.
1074:)
1066:(
1060:)
1051:(
985:e
978:t
971:v
957:.
933::
912:.
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804::
798:4
777:.
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