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For first time ever, FDA clears at-home artificial insemination kit

Anyone who's struggled with infertility knows that getting treatments can be expensive.

Insurance often doesn't cover artificial insemination, a procedure that places sperm into the cervix or uterus during ovulation. It can cost anywhere from $300 to $3,000 each round, and the first try often fails. semen bottle 80ml

For first time ever, FDA clears at-home artificial insemination kit

Other treatments, like in vitro fertilization (IVF) can be even more expensive, running between $15,000 and $30,000 for a singular round.

That means that many people who need such treatments to reproduce often can't afford them. But that could be changing with the introduction of a new at-home artificial insemination kit.

This week, the U.S. Food and Drug Administration cleared the kit for use by consumers. Here's what you need to know, including who makes the kit and how much it costs.

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The new kit was made by Mosie Baby, an Austin, Texas-based company that describes itself as "a pioneering at-home fertility care company."

They have made the Mosie Baby Kit, which is now the first and only FDA-cleared over-the-counter option for intravaginal insemination. According to the company, the kit was found to be "substantially equivalent" to a clinically administered insemination.

The kit is designed for use with either a fresh or cryogenically frozen donor semen sample, meaning those attempting to conceive have a few options for a sperm source and could potentially use an outside donor, according to a company news release on Wednesday.

The kit comes with two syringes and two cups for semen collection. The syringes are described as having a "barrel-free tip and slit opening," which allows for a more direct transfer with minimal waste.

The kits cost $129.99 and are being sold on the company's website, and at cvs.com, walmart.com and optumstore.com.

"Nearly 10 years ago, my husband and I were devastated by a diagnosis of unexplained infertility and were desperate for options that were safe, financially accessible and easy to use at home," said Mosie Baby co-founder and CEO Maureen Brown in a statement.

She said that she and her husband first invented the kit in 2014 and that it has since helped more than 100,000 people conceive. USA TODAY was unable to independently verify that statement.

One in six people is affected by infertility globally, and the rates of infertility are generally consistent among high, low- and middle-income countries, according to the World Health Organization.

Infertility doesn't discriminate, but access to treatment certainly does.

Put simply, infertility is defined as an inability to reproduce by natural means. Roughly 20% of heterosexual, cisgender women in the U.S. struggle to get pregnant after one year of trying, according to the Centers for Disease Control and Prevention. This can be caused by cisgender male factors, such as low sperm count or the ability of sperm to move efficiently, or female factors, such as ovulation disorders or uterine abnormalities.

Other types of people turn to artificial insemination to produce pregnancy as well, such as same-sex couples, single parents by choice or transgender people. Whatever the reason, artificial insemination is a common first step in trying to conceive with medical assistance.

Artificial insemination makes the natural process more direct, placing semen straight into the vagina, cervix, or uterus close to or during ovulation to maximize the chances of fertilization.

There are a few types of artificial insemination available to people trying to conceive. Intracervical insemination is performed in a healthcare setting and entails injecting sperm into the cervix using a syringe. Intrauterine insemination is also performed in a clinical setting and is done by putting sperm into the uterine cavity and then performing sperm washing, which concentrates the sample.

At-home insemination was also an option before the Mosie Baby Kit, but there was no specific over-the-counter kit that was FDA-cleared. With this method, fresh or frozen sperm can be placed at the part of the cervix that attaches to the vagina using a syringe or cup, at home without the help of a professional.

For first time ever, FDA clears at-home artificial insemination kit

Stainless Steel Nose Ring Each method has its own success rate, advantages and drawbacks. Many individual factors go into successful conception but with more affordable at-home options, more people might be able to give it a try.