An intravaginal insemination (IVI) device has become the first of its kind to receive US Food and Drug Administration (FDA) clearance.
The Mosie Baby IVI kit, which has now been granted FDA 501(k) Class II clearance, is available to purchase over the counter and online in the USA. It is designed for use by people who wish to carry out insemination at home, who are unable or opt not to use other methods of insemination.
'Mosie Baby was created to support people facing obstacles to insemination, whether due to the inability to engage in intercourse, or if they choose not to engage in intercourse,' Maureen Brown, founder of Mosie Baby told Yahoo Life.
The kit contains two uniquely designed syringes, without rounded ends and an opening slit rather than a hole, as well as two sperm pots for sample collection. Mosie Baby claims the design of their syringes allows for comfortable injection of the semen sample, while minimising waste. It is suitable for use with both fresh and cryopreserved sperm samples, meaning it can be used by same sex couples using donor sperm.
IVI is not to be confused with intrauterine insemination (IUI) where the sperm sample is placed in the uterus, rather than the vagina. IUI must be carried out in a clinic, meaning it comes at a higher cost than at home insemination methods.
Professor Lauren Streicher, a clinical professor of obstetrics and gynaecology at Northwestern University's Feinberg School of Medicine, Illinois, told Yahoo Life that IVI kits are a 'great alternative for couples in whom vaginal intercourse is uncomfortable or not possible' but emphasised that this method is not a treatment for infertility, as IUI can be.
However, she also stressed: 'These kits involve a little plastic syringe and semen is injected into the vagina... Some of these kits are very expensive, ... All you need is a clean receptacle for sperm and a plastic syringe. You can get a 20-cent syringe from your local drugstore and Amazon.'
In order to gain FDA clearance, the Mosie Baby device had to go through rigorous clinical testing, including the human sperm survival assay for quality control, biocompatibility testing to study the interaction between the device and the tissues and cells that it comes into contact with, and also vaginal irritation testing.