(Bloomberg) -- For many struggling to conceive, an early line of treatment is artificial insemination, a procedure that can cost up to $1,000 and isn’t always covered by insurance. But before taking that step, the startup Mosie Baby wants couples to try it at home, for $129. 

The DIY kit now also comes with the US Food and Drug Administration’s stamp of approval. The Austin-based company Wednesday said it’s the first at-home kit cleared by the agency for intravaginal insemination.

Mosie Baby has been on the market since 2015, but in 2020 the FDA issued a warning letter that said at-home artificial insemination kits would require clearance as Class II medical devices. In June, the FDA cleared Ferti-Lily, a home insemination kit that uses a cervical cup. 

“This is proving that our device has been rigorously tested,” said Mosie Baby Co-Founder and Chief Executive Office Maureen Brown. “It gives confidence to the end user and the medical community that it’s manufactured at a high standard and performs at a high standard.”

Mosie Baby’s kit isn’t the same as intrauterine insemination, or IUI, in which sperm is directly inserted into the uterus by a health-care provider to give it a better chance at fertilizing an egg. That procedure is often accompanied by medication and other testing meant to increase the chances of conception.

Instead, with IVI, sperm is inserted with a syringe into the vagina; it doesn’t go as deep as an IUI and is more akin to what happens during sex. Mosie Baby hopes to be a first-line treatment for those using donor sperm or surrogates, struggling with intimacy or couples simply tired of aligning their schedules for timed intercourse. 

“There are a lot of people who might be frustrated in their journey to conceive who simply want an alternative method to try before moving on to these other procedures,” said Brown.

She and her husband, co-founder and creative director Marc Brown, came up with the idea for the kit after going through IUI themselves and wishing there was an easier, more comfortable option. 

Zev Williams, the head of Columbia University Irving Medical Center’s fertility program, said that for those having difficulty getting pregnant, it’s best to see a doctor to determine what the underlying issue might be. If, for example, a woman has blocked fallopian tubes, there’s no physical way for sperm to make it to the uterus, making any DIY kit useless. 

“I wouldn’t recommend using this without first seeing your OBGYN, who can figure out basic tests to make sure that there’s a potential that this is helpful,” he said. 

Pregnancy outcomes from the kit have not been clinically studied, but a few small studies have found that at-home intravaginal insemination could be an effective and simple way to conceive for couples struggling with sexual dysfunction. Success rates for the more intensive IUI procedure vary between 5% and 15%, according to one analysis. 

Each kit contains equipment for two inseminations. They are available at CVS stores, as well as on Mosie Baby’s website, Walmart.com and through the Optum Store. The company plans to expand to more retail locations in 2024.

The startup raised $1 million in September for a total investment of $2 million. The company said its kits have helped more than 100,000 families try to conceive at home to date. 

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