Information for healthcare professionals
You're not on your own. A team from the Collège de Médecine Générale is here to support you too. You can download their brochure here.
Andro-switch, a silicone ring manufactured and marketed by Thorème, is currently undergoing CE certification as a medical device (MD) for male contraception. Its marketing has been suspended pending certification, following the DPS of 10-12-2021 by the ANSM, as a regulatory precaution and not because of any risk to users.
If one of your patients informs you that they are using or have used the Andro-switch, we recommend that you discuss the potential risks of using this ring with them. Indeed, in the absence of clinical data demonstrating its performance and safety of use, there is nothing to rule out the possibility that use of the Andro-switch could lead to an unwanted pregnancy, could be responsible for possible damage to the health of users, particularly those with hypofertility factors, or could cause health problems for children conceived with this contraceptive device or within 6 months of its discontinuation.
Particular attention should be paid to any discomfort, pain or difficulty in urinating experienced by the ring wearer (potential risk of urethral stenosis).
Finally, the use of another method of contraception is recommended for 2 spermatogenesis cycles, i.e. the 6 months following the end of Andro-switch use. After this period, a spermogram is recommended to monitor fertility.
Here is the Patient Information Form - Informed Consent - France which you can download free of charge.
Over the past 2 years, the thermal method has become a real hit with the general public. For the past 40 years, this practice has been used by many people through activist networks, family planning organizations, general practitioners and various university hospitals such as Toulouse. Although it has not yet been granted marketing authorization, everything is being done to ensure that a well-supervised practice develops in parallel with the steps required for regulatory standardization.
"My first concern will be to restore, preserve or promote health in all its elements, physical and mental, individual and social. I will respect all people, their autonomy and their will, without any discrimination according to their condition or beliefs. "Extract from the Hippocratic Oath
This is a brief information page on the topic to help you get started.
Male thermal contraception (MTC) medical protocol
- Pre-contraceptive visit: Anamnesis - palpation - jockstrap fitting
testicular - spermogram
- If the person is eligible for the method, start 15 hours of 24-hour wear, 7 days a week for 3 months, with use of another contraceptive method at the same time.
- À 3 mois : spermogramme, si la concentration est < 1 million-ml toutes
regardless of mobility, the person is considered to be contracepted.
- Thereafter, a quarterly spermogram should be performed.
- If the jockstrap is not worn for more than one day a month, use another method of contraception for one month and have a follow-up spermogram.
- Possible for 4 consecutive years, followed by a break on the principle of
precaution, as the method has only been validated over 4 consecutive years.
- Stop: Use contraception until you return home
within WHO spermogram standards, usually 3 to 6 months. This is to remove altered sperm as described in the side effects section. Carry out a spermogram at 3 months, then every month until the sperm returns to normal.
- Source :
Soufir JC ; Mieusset R ; A practical guide to male contraception
hormonal or thermal Andrology (2012) 22:211-215
Find a summary of the protocol on the website of theFrench Association of Urologists
Browse the summary of French teams' contributions to the development of male contraception in 2017.
Clinical research Male thermal contraception (MTC)
1985 Mieusset, R., Grandjean, H., Mansat, A. and Pontonnier, F. 1985. Inhibiting effect of artificial cryptorchidism on spermatogenesis.Fertil. Steril. 43: 589.
1986 Mansat, A., Mieusset, R., Bujan, L. and Pontonnier, F. 1986. Alteration morphologique des spermatozoides sous l'influence d'un facteur exogene.Bull. Ass. Anat. 211 bis: 59.
1987 Mieusset, R., Bujan, L., Mansat, A., Pontonnier, F. and Grandjean, H. 1987a. Hyperthermia and human spermatogenesis: enhancement of the inhibitory effect obtained by "artificial cryptorchidism".Int. J. Androl., 10: 471. &
1987 Mieusset, R., Bujan, L., Mansat, A., Pontonnier, F. and Grandjean, H. 1987b. Effects of artificial cryptorchidism on sperm morphology.Fertil. Steril, 47: 150.
1988 F. R. Kandeel and Swerdloff R. S., "Role of temperature in regulation of spermatogenesis and the use of heating as a method for contraception", Fertil Steril, vol. 49, no. 1, January 1988, pp. 1-23
1991 Mieusset R., Bujan L., Mansat A., Grandjean H., Pontonnier F. (1991) Heat Induced Inhibition of Spermatogenesis in Man. In: Zorgniotti A.W. (eds) Temperature and Environmental Effects on the Testis. Advances in Experimental Medicine and Biology, vol 286. Springer, Boston, MA
1991 Shafik A. Testicular suspension as a method of male contraception: technique and results. Adv Contr Deliv Syst. 1991;VII:269-79.
1992 Shafik A. Contraceptive efficacy of polyester-induced azoospermia in normal men. Contraception. 1992;45:439-51.
1994 MIEUSSET R., BUJAN L.: The potential of mild testicular heating as a safe, effective and reversible contraceptive method for men. Int. J. Androl, 1994 ; 17 : 186-191.
2010 Zhu H, Cui Y, Xie J, Chen L, Chen X, Guo X, et al. "Proteomic analysis of testis biopsies in men treated with transient scrotal hyperthermia reveals the potential targets for contraceptive development". Proteomic analysis of testis biopsies in men treated with transient scrotal hyperthermia reveals the potential targets for contraceptive development." Proteomics. 2010;10:3480-93.
2012 Ahmad G, Moinard N, Lamare C, Mieusset R, Bujan L. Mild testicular and epididymal hyperthermia alters sperm chromatin integrity in men. Fertil Steril. 2012;97:546-53.
2019 Abdelhamid MHM, Esquerre-Lamare C, Walschaerts M, Ahmad G, Mieusset R, Hamdi S, Bujan L.Experimental mild increase in testicular temperature has drastic, but reversible, effect on sperm aneuploidy in men: A pilot study. Reprod Biol. 2019 Jun 14.
Summary of scientific data:
15 clinical studies
More than 122 volunteers
(4 studies with unspecified number of volunteers).
- +-2°C body self-heating in the inguinal pouch
- 15 hours/d, 7j/7, maximum duration 48 months
Over 1,331 exhibition cycles
1 unwanted pregnancy due to incorrect use of the method
- Reversibility: 100% in 2 to 3 spermatogenesis cycles.
- Side effect identified and reversible within 2 to 3 spermatogenesis cycles: 10 to 15% reduction in testicular volume,
- Identified adverse effects reversible within 2 to 3 spermatogenesis cycles: altered chromatin integrity & altered chromosome number.
Medical follow-up & number of volunteers outside clinical trials :
2005 - present: For the past 14 years, the Toulouse University Hospital has been partly financing a consultation and rigorous medical follow-up for couples wishing to use this method. It seems difficult to imagine that the Toulouse University Hospital would finance a consultation and medical follow-up without it being justified by a real demand from people who need to contracept. Couples and/or boys have been making their own testicular enhancement tools based on heated briefs for several years now, with the Ardecom association and the Thomas Bouloù collective, in a militant approach often followed by general practitioners, with or without a link to the Toulouse University Hospital.
Based on this assumption, and in addition to the clinical trials, it is possible to estimate the number of users of this method at a minimum of 80 and a maximum of 1000, over 14 years and medically monitored for an average of 12 months. The order of magnitude of the number of people, excluding clinical trials, using or having used this method, would be 80. No unwanted pregnancies were reported over this period, and all the boys or couples who wanted to have a child were able to do so normally. It is reasonable to estimate the number of exposure cycles over the last 14 years in medical follow-up excluding clinical trials at 960, for 0 unwanted pregnancies.
Ability to use suspension tools
Whatever the tool, textile or silicone, it must keep the testicles in a supra-scrotal position during activities of daily living.
Determine whether the model is suitable :
- A tool is too big when, despite these application, it doesn't hold and a testicle falls back under the tool. As long as the testicles are above or at the same level as the tool, the testicles are exposed to body heat.
- A tool is too small when it will mark your skin like a sock marks the skin of your calf, and when erections don't resolve naturally. This means your penis is still gorged with blood from too much compression. In that case, take it off.
Readjust models: Whatever the tool, get in touch with activist networks or return to the thoreme team if the tool isn't suitable.
Browse the " using the ring " protocol page to visualize testicular ascent.
Undesirable effects
Very common :
- Testicular volume reduced by 10-15% - 99
- Discomfort during sporting activities 14.35
- Local irritation or itching 25.24
Common :
- Pain during erections 3.96
- Pain at night 4.45
- Daily discomfort 6.93
- Pulls pubic hair 6.93
Undetermined frequency:
- Reversible alteration of chromatin integrity (Ahmad et al. Fertil. Steril. 2012)
- Reversible sperm aneuploidy (Abdemhamid et al. Reprod. Biol. 2019)
- Loss of sensation during intercourse
- Pollakiuria - urethral stricture
- Temporary back pain
- Motion reduction
- Allergic reactions
Resulting from an evaluation carried out on 200 volunteers in 2020, others will follow shortly.
Contraindications
- Any abnormality of the pubic groin, penis, groin and testicles,
- Treatment of inguinal hernias, testicular torsion: orchidopexy or closure of inguinal canals can prevent mechanical testicular ascent,
- Testicular cancer,
- Grade 3 hydrocele,
- Reduced hand strength,
- Obesity (BMI > 30),
- Local skin infections of the penis, scrotum, groin and pubic area, contact dermatitis of the penis, scrotum, groin and pubic area, edema of the penis.
- Spermogram considered abnormal: sperm concentration less than 15 million/ml, progressive motility less than 32%.
Disclaimer: The information provided in this FAQ is based on user testimonials and is for general information purposes only. It does not constitute medical advice, diagnosis or professional treatment. We are not medical doctors. Always consult a qualified healthcare professional for personalized and appropriate medical advice. We accept no responsibility for any consequences arising from the use of the information provided in this FAQ. Send us an e-mail.
