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FDA approves first at-home sterile insemination kit to help with infertility: 'Gives me goosebumps'

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FDA approves first at-home sterile insemination kit to help with infertility: 'Gives me goosebumps'

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It’s now possible for women to get pregnant via insemination in the comfort of their own homes.

The FDA recently approved the first-ever, at-home sterile insemination kit. 

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PherDal Fertility Science received clearance last month after various tests did not raise “any new questions on the safety or effectiveness” of the product, as stated in the FDA’s approval letter.

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PherDal’s creator and CEO, Dr. Jennifer Hintzsche of Dixon, Illinois, confirmed to Fox News Digital that there have been 34 babies born from the first 200 proof-of-concept kits that were released.

“Even saying that still gives me goosebumps,” Hintzsche said in an interview.

Dr. Jennifer Hintszche is pictured with her husband, Ryan Westphal, and their two children, Lois and Zackary, in a 2019 portrait. (Brittany Moore )

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The at-home kit is intended for users who are struggling to conceive or have chosen not to conceive naturally. 

The kit includes three sterile, circular cups and three syringes, all packaged separately, for an independent-use option.

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While other brands offer at-home insemination kits, PherDal is the only multi-patented, sterile, FDA-cleared at-home insemination device on the market, according to the company. 

“Sterility matters because studies show that disruptions (dysbiosis) in the reproductive microbiome are linked directly to infertility,” said Hintzsche.

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The Hintszches are pictured with their daughter, Lois, on the left. Right, the PherDal syringe and circular sterile cup enable full access to samples. “If you’re paying $3,000 for a few milliliters of a sample, every drop counts,” Hintzsche said. (Don Umland Photography/PherDal)

PherDal’s first batch of kits sold out in just 90 days, which is when Hintszche realized she might be “on to something.”

“It really is a simple device, but there’s so much science behind its effectiveness,” she said. 

Driven by desire for family

Hintzsche said she assumed that after she married her husband in Oct. 2016, she would get pregnant, have multiple babies and live happily ever after “behind a white picket fence.”

But after 14 months of unsuccessful conception efforts, she sought out a fertility specialist who ran some tests.

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That’s when Hintzsche discovered that she had “unexplained infertility,” as the doctor said that “everything looks normal” and “we don’t know what’s wrong.”

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The doctor then handed Hintzsche an application for a $10,000 loan to begin IVF treatment.

As a biologist with a PhD, Hintzsche started digging into infertility research in search of an alternative to “invasive” treatments.

After marrying her husband in Oct. 2016, Hintzsche tried unsuccessfully for 14 months to get pregnant before seeking out a fertility specialist. (PherDal)

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“Instead of going into the uterus, if you put [sperm] right at the opening of the cervix, and it was done [in a] sterile [manner] in the clinic, it had the same live birth rate [as IVF],” she said. “And I was like, ‘Why has no one ever offered me this?’”

The scientist ordered lab supplies and gave her prototype a try.

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Hintzsche got pregnant in Dec. 2017, after only two attempts with the kit. 

Her daughter, Lois, was born on Sept. 11, 2018.

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Motivated by that success, Hintzsche launched a new career with the goal of helping other people who were facing the same struggles.

Dr. Jennifer Hintszche of Illinois and her family are pictured cheering on the Chicago Bears in 2023. (Dr. Jennifer Hintzsche)

“I think everyone deserves something they can try first, and it shouldn’t take $10,000 just to [have the chance] to become a mother.”

Through feedback from PherDal customers, Hintzsche has fine-tuned her product to accommodate a variety of scenarios.

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Many women report feeling “shame” when they face infertility, Hintzsche said — which is something PherDal aims to eliminate.

From other PherDal moms, Hintzsche has also heard that at-home insemination “takes the pressure off” couples who have gone to great lengths to conceive without success.

Many PherDal dads have reported that they’d rather not return to a clinic to provide a sample, since “that’s not the way they envisioned growing a family,” Hintszche said.

Another family, shown here, used PherDal to conceive their child.  (Camber Lynn Ostwinkle, Wink Photographs)

“It gives people this private, safe option that doesn’t [involve] any drugs,” Hintzsche said. “It’s not going to work for everyone … but for a lot of people, maybe the sperm just needs a little boost.”

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It’s important for people to confirm with their doctor that it is healthy for them to become pregnant before attempting a method like PherDal, she added.

Infertility specialist sees promise, warns of potential pitfalls

Dr. Remm Sabouni, a reproductive endocrinologist and infertility specialist at Aspire Houston Fertility Institute, shared with Fox News Digital her appreciation for reproductive products that allow “more choice while maintaining safety.” (She was not involved in PherDal’s development.)

The expert noted that PherDal is potentially useful for members of the LGBTQIA+ community who would like to try at-home insemination.

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It is also useful for patients who have undergone infertility evaluation and are seeking more natural options, she said, or for male partners who have erectile issues or who want to avoid intercourse as a means of producing sperm.

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Sabouni did point out one “major caveat” of a product like PherDal, which is the challenge of understanding who qualifies as a good candidate for its use.

Dr. Hintzsche, pictured with her husband, named the product PherDal because she used her PhD to “prove” she was fertile, she said. (Dr. Jennifer Hintzsche)

The fertility expert cautioned about “some pitfalls,” including lack of fertility assessment and limited efficacy for certain medical conditions such as male factor infertility, tubal blockages or ovulatory disorders in women.

Sabouni also mentioned a lack of randomized controlled trials “demonstrating the viability of this treatment” — as well as the lack of medical supervision and the risk of misuse.

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“While I recognize the potential benefits of such devices for at-home use, particularly for individuals and couples trying to conceive, I would strongly caution that they not be seen as a replacement for consulting with a fertility specialist,” she said. 

“If conception is not achieved after using these methods for a recommended period (typically a year for those under 35, and six months for women over 35 or with irregular periods), it is advisable to seek professional medical advice,” the doctor added.

“I think everyone deserves something they can try first, and it shouldn’t take $10,000 just to [have the chance] to become a mother,” said the company’s founder (not pictured). (iStock)

Customers do not need a prescription to purchase.

FDA clearance advises that consumers should only purchase the product for up to six months before seeking other options.

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“It really is just an affordable and accessible way that people can try if they’re struggling,” Hintzsche said.

Fox News Digital reached out to the FDA requesting comment.

The company said that pre-orders for PherDal kits, which are 100% made in the USA, are currently available at pherdal.com for $199.

For more Health articles, visit www.foxnews.com/health.

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Health

5 winter-weather essentials to protect skin health in dangerously cold temperatures

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5 winter-weather essentials to protect skin health in dangerously cold temperatures

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As winter weather moves in, cozy essentials like scarves, plush throws and heated bedding become everyday comforts. 

But dermatologists caution that these cold-weather favorites can secretly undermine skin health — trapping sweat and bacteria, causing irritation and exposing the skin to excess heat. 

Choosing the right materials for wellness — and using them safely — can make a big difference. 

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Here are five winter must-haves and gift ideas, with expert tips on how to keep skin healthy and happy while staying warm this season.

Soft scarf, $19.99, Amazon.com

Scarves made of natural fiber, like this one that is 100% cotton, may help if you’re prone to irritation. (Amazon)

A soft scarf is a staple for cold days and an easy way to elevate a winter outfit.

Yet, if breakouts are appearing along the neck, jawline or chest, that favorite accessory may be part of the problem.

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“You should wash your scarf as often as your clothes to prevent breakouts,” Annabelle Taurua, a beauty expert at Fresha, a beauty and wellness booking platform headquartered in London, told Fox News Digital.

Cotton is a better choice than polyester, she also noted, as it’s more breathable and allows sweat to evaporate.

Fluffy blankets, $28.97, Potterybarn.com

Fluffy blankets make for perfect cozy days at home, but their soft fibers can trap sweat, oils and dead skin — which can clog pores and encourage bacteria growth. (Pottery Barn)

Fluffy blankets make for perfect cozy days at home, but their soft fibers can trap sweat, oils and dead skin, which can clog pores and encourage bacteria growth. 

Rough textures or infrequent washing can also irritate sensitive skin and worsen breakouts.

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“Regularly wash your blankets, especially those made from synthetic or fluffy materials, to remove built-up oils and dirt,” Taurua advised.

She recommended breathable materials like cotton or linen, as well as hypoallergenic options for anyone prone to irritation.

Good set of sheets, $49.99, Amazon.com

Much like scarves, natural fibers are the way to go for your linens to avoid irritation. (iStock)

Cold weather makes lingering in bed especially tempting, but lying on unwashed bedding can worsen acne.

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Pillowcases and sheets quickly collect oil, bacteria and dead skin cells, which transfer directly onto the face.

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“Washing bedding frequently is important,” Taurua said. “You should aim to change and wash your pillowcases every two to three days and your sheets at least once a week.”

Heated blanket, $33.99, Walmart.com

Heated blankets are a great way to stay warm during the winter. (Walmart)

When using a heated blanket, start with the lowest heat setting and limit use, said Taurua.

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“Once you’re warm, switch to a regular blanket,” she advised.

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She also said it’s best to avoid direct contact for long periods to reduce irritation.

Hot water bottle, $12.99, Amazon.com

A traditional winter staple, hot water bottles offer quick comfort — but they come with risks similar to heated blankets, including burns, scalding and long-term heat-related skin damage.

Hot water bottles should never be filled with boiling water, experts advise. (Amazon)

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“Never fill a hot water bottle with boiling water,” Taurua said. 

“Only use hot, not boiling, water, and fill it to a maximum of two-thirds.”

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She recommended wrapping the bottle in a towel or cover to avoid direct skin contact and limiting use to around 20 minutes.

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Foods and Drinks That Help With Bloating: Flatten Your Belly in Days

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Foods and Drinks That Help With Bloating: Flatten Your Belly in Days


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What to know about Cushing’s syndrome, which led to Amy Schumer’s dramatic weight loss

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What to know about Cushing’s syndrome, which led to Amy Schumer’s dramatic weight loss

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Comedian Amy Schumer, 44, has recently come clean about her struggle with Cushing’s syndrome, leading to a dramatic weight loss.

Schumer’s transformation has sparked conversation online, to which she responded in a now-deleted Instagram post that shut down speculation about cosmetic enhancements.

“I didn’t lose 30lbs — I lost 50,” she emphasized on social media, adding that she does not get Botox or filler.

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Schumer doubled down that her weight loss was not about her appearance, but about staying alive.

“Not to look hot, which does feel fun and temporary,” she said. “I did it to survive. I had a disease that makes your face extremely puffy that can kill you, but the internet caught it and that disease has cleared.”

Amy Schumer attends Variety’s 2024 Power of Women: New York event on May 2, 2024, in New York City on the left. On the right, Schumer later poses for a photo posted to Instagram after her weight loss. (Marleen Moise/WireImage; Amy Schumer/Instagram)

“Sorry for whatever feeling it’s giving you that I lost that weight,” she added. “I’ve had plastic surgery over the years and I use [Mounjaro]. Sorry to anyone they let down. I’m pain free. I can [play] tag with my son.”

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The actress also addressed her shifting hormones, saying that she’s “happy to share more if anyone has any questions about how I’m looking or feeling or where I am in my perimenopause process.”

“I didn’t lose 30lbs — I lost 50,” Schumer emphasized on social media, adding that she does not get Botox or filler. (Amy Schumer/Instagram)

What is Cushing’s syndrome?

Schumer previously revealed that she had been diagnosed with Cushing’s syndrome, a hormonal disorder that can cause extreme swelling, fatigue and potentially fatal complications.

Dr. Peter Balazs, a hormone and weight loss specialist in New Jersey, provided more details on the condition in an interview with Fox News Digital.

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“Cushing’s syndrome is caused by prolonged, high exposure to cortisol, which is your body’s main stress hormone,” he said. “Usually, the excess cortisol is a result of prolonged steroid use. We see this many times with patients who have some autoimmune disorder.”

Balazs said the “key” to Cushing’s syndrome is not just weight gain, but a “specific redistribution” of fat caused by too much cortisol.

Amy Schumer is photographed during a guest interview on The Tonight Show Starring Jimmy Fallon on Feb. 13, 2024 (left), and later seen walking through midtown New York City on Oct. 28, 2025 (right). (Todd Owyoung/NBC via Getty Images; Raymond Hall/GC Images/Getty Images)

Fat may be driven to the abdomen, chest, upper back (referred to as a “buffalo hump”) or face, sometimes considered “moon face,” the doctor said.

Cortisol also breaks down protein, which leads to a thinning in the arms and legs. “Weight gain can be tough, involuntary and hard to manage,” Balazs added.

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Cortisol stimulates “hunger centers” in the brain, raises blood sugar and promotes fat storage, especially deep belly fat, according to the doctor.

Cushing’s syndrome can also cause high blood pressure, bone loss and sometimes type 2 diabetes, per Mayo Clinic.

In addition to weight gain in certain areas, other symptoms may include pink or purple stretch marks on the stomach, hips, thighs, breasts and underarms, as well as acne, slow wound healing, and thin, frail skin that bruises easily.

With Cushing’s syndrome, fat may accumulate in the abdomen, chest, face or upper back (referred to as a “buffalo hump”). (iStock)

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Women with Cushing’s syndrome often experience thick, dark hair on the face and body, as well as irregular periods. Symptoms among men can include a lower sex drive, reduced fertility and erectile dysfunction.

Mayo Clinic listed other potential symptoms, including extreme fatigue, muscle weakness, depression, anxiety, irritability, mood swings, trouble with concentration and memory, headache, sleeplessness, skin darkening and stunted growth in children.

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Those with symptoms should contact their doctor immediately, especially if they are taking steroids to treat health issues like asthma, arthritis or inflammatory bowel disease, as these medications can exacerbate the condition.

The Mayo Clinic has reported that the “sooner treatment starts, the better the chances for recovery.”

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“I’ve had plastic surgery over the years and I use [Mounjaro],” Schumer stated in a social media post. (George Frey/Bloomberg)

For patients like Schumer, weight loss is typically not the main goal, Balazs noted, but it is a “critical sign” of successful treatment.

“The primary goal is to normalize your high cortisol levels,” he said. “I believe Amy Schumer got treated first for her underlying problem. Once the cortisol is normalized, which is the most important step, there’s a role to use adjunct medications to decrease weight.”

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Among GLP-1s, Mounjaro is an “excellent choice to decrease deep belly fat and increase insulin sensitivity of cells,” Balazs added.

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Fox News Digital’s Stephanie Giang-Paunon contributed to this report.

Fox News Digital reached out to Schumer’s rep requesting comment.

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