37.1 CONTRACEPTIVE BOXER
DESCRIPTION
The 37.1 contraceptive boxer is a contraceptive medical device currently in development.
An elegant and functional everyday contraceptive undergarment, the 37.1 contraceptive boxer will be an essential piece of the male wardrobe. Intended as a reliable alternative to conventional contraceptive methods, it will provide thermal male contraception by testicular lifting (TMC): a natural, reversible, non-invasive and hormone-free method.
An understated look, a clean, contemporary design, discreet and ingenious technology. The 37.1 boxer will have a transverse pocket to make the daily TMC routine easier: it will slip on in a few seconds. Inside, a soft, cushioned and adjustable ring structure will keep the testicles warm inside the body, at 37°C.
The precise, quick adjustment system will make it easy to adjust the boxer at any time of day. It will adapt to your body shape and follow all your movements. On the outside, a wide elastic waistband will ensure optimal comfort.
Carefully selected materials, an ergonomic cut and premium finishes will make it an ideal everyday companion, designed to combine comfort, effectiveness and style.
RESEARCH
The 37.1 contraceptive boxer will go through several design phases: sketches, modelling, mock-ups, prototypes, fittings and size grading. Many rounds between pattern maker, manufacturer and testers will be needed to reach the final version.
The 37.1 contraceptive boxer will then have to undergo preclinical trials (biocompatibility, durability, usability) and clinical trials (study of safety and effectiveness in testers) before being placed on the market.
PRINCIPLE
The 37 DEGRÉS 37.1 contraceptive boxer is designed to provide thermal contraception by testicular lifting. It will mechanically lift the testicles and hold them above the scrotum. Their temperature then rises, approaching that of the rest of the body: 37 °C. At this temperature, sperm production is impaired and fertility decreases.
If this is done every day, fertility decreases enough to achieve contraception.
To understand the method, the protocol and the reasons behind it, read the Thermal contraception and Scientific resources and references pages.
THE MEDICAL CERTIFICATION PROCESS
ISO 13485 STANDARD
ISO 13485 is the international reference framework for medical devices.
It governs our entire quality management system, from design to production, including inspections and traceability.
This standard ensures that every stage of our product development meets strict requirements for safety, reliability and regulatory compliance.
PRECLINICAL TRIALS
Before any evaluation in humans, the device will undergo in-depth preclinical trials.
These tests will aim in particular to check the biocompatibility of the materials used, in order to rule out any risk of irritation or allergic reaction.
They will also make it possible to validate the device’s performance and its durability over time, by simulating real conditions of use.
CLINICAL TRIALS
Clinical trials aim to demonstrate the safety, effectiveness and real benefit of the device under conditions of use.
We have already designed the protocol for a clinical study of the 37.1 boxer, and this study is scheduled to start during 2027, subject to the necessary authorisations.
CE MARKING
For this class of device, CE marking requires certification by an independent notified body, which assesses the device’s entire technical documentation.
This documentation includes, in particular, elements relating to the quality system, preclinical trials and clinical data.
At the end of this assessment, the notified body certifies that the device complies with European requirements and can be used safely, with a demonstrated level of performance.
