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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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Holiday heart attacks rise as doctors share hidden triggers, prevention tips

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Holiday heart attacks rise as doctors share hidden triggers, prevention tips

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The holidays are known to be a source of stress, between traveling, preparing for family gatherings and indulging in lots of food and drinks.

The uptick of activity can actually put a strain on the heart, a phenomenon known as “holiday heart syndrome.”

Cardiothoracic surgeon Dr. Jeremy London addressed this elevated risk in a recent Instagram post, sharing how heart attacks consistently rise around the holidays.

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“Every year, like clockwork, we see a spike in heart attacks around Christmas and New Year’s,” the South Carolina-based surgeon said. “In fact, Christmas Eve is the highest-risk day of the year.”

This is due to a shift in behavior, specifically drinking and eating too much, moving less and being stressed out, according to London. “Emotional stress, financial stress, the increased pace of the holidays, increased obligations,” he listed.

Cold weather also causes vasoconstriction (narrowing of blood vessels), according to London, which increases the risk of plaque rupture and the potential for heart attack.

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Dr. Glenn Hirsch, chief of the division of cardiology at National Jewish Health in New York, noted in an interview with Fox News Digital that holiday heart syndrome typically refers to the onset of an abnormal heart rhythm, or atrial fibrillation.

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This can happen after an episode of binge-drinking alcohol, Hirsch said, which can be exacerbated by holiday celebrations.

Binge-drinking at any time can drive atrial fibrillation, a cardiologist cautioned. (iStock)

“It’s often a combination of overdoing the alcohol intake along with high salt intake and large meals that can trigger it,” he said. “Adding travel, stress and less sleep, and it lowers the threshold to go into that rhythm.”

The biggest risk related to atrial fibrillation, according to Hirsch, is stroke and other complications from blood clots. Untreated atrial fibrillation can lead to heart failure after a long period of time.

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“The risk of atrial fibrillation increases with age, but also underlying cardiovascular disease risk factors increase the risk, such as high blood pressure, obesity, diabetes, sleep apnea and chronic kidney disease,” he added.

Christmas Eve is the “highest risk day of the year” for heart attacks, according to one cardiologist. (iStock)

Preventing a holiday heart event

Holiday heart syndrome is preventable, as Hirsch reminds people that “moderation is key” when celebrating.

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The expert recommends avoiding binge-drinking, overeating (especially salty foods) and dehydration, while managing stress levels and prioritizing adequate sleep.

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“Don’t forget to exercise,” he added. “Even getting in at least 5,000 to 10,000 steps during the holiday can help lower risk, [while] also burning some of the additional calories we are often consuming around the holidays.”

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London agreed, stating in his video that “movement is medicine” and encouraging people to get out and move every day.

The various stresses of the holidays can have physical consequences on the body, doctors warn. (iStock)

It’s also important to stay on schedule with any prescribed medications, London emphasized. He encourages setting reminder alerts, even during the holiday break.

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“Prioritize sleep and mindfulness,” he added. “Take care of yourself during this stressful time.”

London also warned that many people delay having certain health concerns checked out until after the holidays, further worsening these conditions.

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“Don’t ignore your symptoms,” he advised. “If you don’t feel right, respond.”

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‘Aggressive’ new flu variant sweeps globe as doctors warn of severe symptoms

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‘Aggressive’ new flu variant sweeps globe as doctors warn of severe symptoms

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Flu season is among us, and a new strain has emerged as a major threat.

Influenza A H3N2, or the subclade K variant, has been detected as the culprit in rising global cases, including in the U.S.

In an interview with Fox News Digital, Dr. Neil Maniar, professor of public health practice at Boston’s Northeastern University, shared details on the early severity of this emerging strain.

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“It’s becoming evident that this is a pretty severe variant of the flu,” he said. “Certainly in other parts of the world where this variant has been prevalent, it’s caused some severe illness, and we’re seeing an aggressive flu season already.”

Influenza A H3N2, or the subclade K variant, has been detected as the culprit in rising global cases. (iStock)

The variant seems to differ from prior strains of the flu, with heightened versions of typical symptoms like fever, chills, headache, fatigue, cough, sore throat and runny nose.

Subclade K is the “perfect storm” for an aggressive flu season, Maniar suggested, as vaccination rates overall are down and this year’s flu vaccine does not address this specific strain.

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“The vaccine is very important to get, but because it’s not perfectly aligned with this variant, I think that’s also contributing to some degree to the severity of cases we’re seeing,” he said. “We’re going in [to this flu season] with lower vaccination rates and a variant that in itself seems to be more aggressive.”

“There’s a lot of concern that this could be a particularly difficult flu season, both in terms of the total number of cases [and] the severity of those cases.”

Staying indoors during the colder months increases the risk of exposure to winter illness. (iStock)

Because subclade K is “quite different” from prior variants, Maniar said there is less natural immunity at the community level, further increasing the risk of spread and severity.

Those who are unvaccinated are also at risk of experiencing more severe symptoms, as well as a higher risk of hospitalization, the doctor emphasized.

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In addition to getting vaccinated, the doctor recommends washing hands frequently and properly. While the flu can spread via airborne transmission, a variety of other illnesses, like norovirus, can stick to surfaces for up to two weeks, he added.

The holiday season also boosts the risk of infection, as gatherings, large events, and packed planes, trains and buses can expose people to others who are sick.

The flu vaccine can help to prevent hospitalization and reduce severe symptoms, doctors agree. (iStock)

Those who are not feeling well or exhibiting symptoms should “please stay home,” Maniar advised — “especially if you think you are in that contagious period of the flu or any of these other illnesses that we’re seeing … whether it’s norovirus or COVID or RSV.”

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“If you’re not feeling well, stay home. That’s a great way to recover faster and to ensure that you’re not going to get others around you sick.”

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For those who are unsure of their health status or diagnosis, Maniar recommends seeing a healthcare provider to get tested. Some providers may be able to prescribe medication to reduce the severity and duration of the illness.

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“It’s important that everyone stays vigilant and tries to take care of themselves and their families,” he added.

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Are you too old to shovel snow? Experts reveal the hidden heart risks

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Are you too old to shovel snow? Experts reveal the hidden heart risks

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As snow blanketed parts of the U.S. this week, heart health experts have shared warnings of the physical strain shoveling can take — particularly for older adults.

A 2025 Mayo Clinic review found that just 10 minutes of heavy snow shoveling can push the heart to about 97% of its maximum rate. Exposure to cold air was also found to increase blood pressure and reduce coronary blood flow.

While there isn’t an official age that’s “too old” to shovel, some cardiologists recommend that individuals over 45 should exercise more caution to lower their chances of a cardiac event.

When to take caution

“While there’s no strict age cutoff, generally above the age of mid 40s and above, we tend to be a little more cautious — particularly in people who are less active [without] regular exercise,” Dr. Navjot Kaur Sobti, M.D., an interventional cardiologist at Northwell’s Northern Westchester Hospital in Mount Kisco, New York, told Fox News Digital.

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Heart health experts have shared warnings of the physical strain shoveling can take — particularly for older adults. (iStock)

“Certainly in people who are above the age of 65 — and who have risk factors for heart disease, such as high blood pressure, high cholesterol, diabetes, obesity or sedentary lifestyle — we recommend being very, very cautious about shoveling snow,” she advised. 

Dr. John Osborne, M.D., a practicing Texas cardiologist and volunteer for the American Heart Association, shared similar guidance for people older than 45, especially males over 65.

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“Unless you are in good cardiovascular shape and conditioned, it may be a good idea to ask someone for help,” he said in an interview with Fox News Digital.

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The impact of snow removal is especially concerning for those with existing cardiovascular risks and a history of heart attack or stroke, according to the cardiologist. “People with these characteristics and those who have had bypass surgery or coronary angioplasty simply should not be shoveling snow in any conditions,” he said.

Just 10 minutes of heavy snow shoveling can push the heart to about 97% of its maximum rate, a 2025 Mayo Clinic review found. (iStock)

Osbourne said he often sees cardiac episodes in people who are typically sedentary and sit at a computer most of the day with little or no exercise. “Then once or twice a year, they go out and try to shovel the driveway after a heavy snowfall, and that unexpected exertion can unfortunately lead to tragedy.”

Hidden strain

The stress that is placed on one’s heart while shoveling snow is similar to what occurs during a cardiac stress test, Sobti pointed out, and may even exceed it.

Cold temperatures can cause blood vessels to constrict and blood pressure to spike — which, coupled with existing hypertension and the exertion of lifting snow, can significantly tax the heart, she warned.

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“It’s almost like an at-risk person is putting themselves through an unsupervised maximal exertion stress test without a cardiologist actively monitoring them,” Sobti told Fox News Digital.

The stress that is placed on one’s heart while shoveling snow is similar to what occurs during a cardiac stress test. (iStock)

In addition to the exertion of shoveling, frigid temperatures can also strain the heart. Recent research has shown that cold exposure accounts for nearly twice as many cardiovascular deaths as heat exposure, including heat exhaustion.

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That study, published in the Annals of Internal Medicine last month, also found that those over age 65 had higher rates of temperature-related deaths.

“So the risk is very, very high,” Sobti cautioned. “It’s really that sudden rise in blood pressure coupled with the physical stress of snow shoveling itself.”

Safer shoveling tips

The cardiologist said it’s ideal to have someone else help with snow removal — but if you do choose to use a shovel, she recommends pacing yourself and using a “pushing or sweeping” motion instead of heavy lifting.

Recent research has shown that cold exposure accounts for nearly twice as many cardiovascular deaths as heat exposure. (iStock)

To protect against the cold, Sobti also recommends covering your mouth, nose and extremities, wearing a hat and gloves, and using extra caution in windy conditions.

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Using an automated snow blower can still raise the heart rate — up to 120 beats per minute, compared to 170 while shoveling, the American Heart Association states on its website.

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It is also important to be aware of any symptoms of a potential cardiac issue while shoveling, Sobti emphasized.

If a person starts to experience warning signs such as chest pain, shortness of breath, a racing heart or palpitations, those should not be ignored.

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Even if the symptoms resolve after a few minutes, a person “could still be experiencing symptoms of a heart attack” and should call 911 for evaluation, Sobti said.

“It’s better really to be safe than sorry.”

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