Health
FDA approves first at-home sterile insemination kit to help with infertility: 'Gives me goosebumps'
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.
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 )
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.
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.
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)
“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.
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.”
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.
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.
“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.
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A new study suggests that middle-aged men may be more vulnerable to faster biological aging, potentially linked to exposure to “forever chemicals.”
The research, published in the journal Frontiers in Aging, examined how perfluoroalkyl and polyfluoroalkyl substances, more commonly known as PFAS, could impact aging at the cellular level.
PFAS are synthetic chemicals commonly used in nonstick cookware, food packaging, water-resistant fabrics and other consumer products, the study noted.
Their chemical structure makes them highly resistant to breaking down, allowing them to accumulate in water, soil and the human body.
Chinese researchers analyzed blood samples from 326 adults enrolled in the U.S. National Health and Nutrition Examination Survey between 1999 and 2000.
A new study suggests that middle-aged men could face accelerated biological aging at the cellular level due to exposure to PFAS. (iStock)
The researchers measured levels of 11 PFAS compounds in participants’ blood and used DNA-based “epigenetic clocks” — tools that analyze chemical changes to DNA to estimate biological age — to determine how quickly their bodies were aging at the cellular level, the study stated.
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Two compounds, perfluorononanoic acid (PFNA) and perfluorooctanesulfonamide (PFOSA), were detected in 95% of participants.
Higher concentrations of those chemicals were associated with faster biological aging in men of certain age groups, but not in women.
“People should not panic.”
The compounds most strongly linked to accelerated aging were not the PFAS chemicals that typically receive the most public attention, the researchers noted.
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“The associations were strongest in adults aged 50 to 64, particularly in men,” Dr. Xiangwei Li, professor at Shanghai Jiao Tong University School of Medicine and the study’s corresponding author, told Fox News Digital.
“While this does not establish that PFAS cause aging, it suggests that these widely present ‘forever chemicals’ may be linked to molecular changes related to long-term health and aging.”
The study found that two of the compounds were detected in 95% of participants, and higher levels were linked to faster biological aging in men ages 50–64. (iStock)
Midlife may represent a more sensitive biological period, when the body becomes more vulnerable to age-related stressors, according to the researchers.
Lifestyle factors, such as smoking, may influence biological aging markers, potentially increasing vulnerability to environmental pollutants.
While Li said “people should not panic,” she does recommend looking for reasonable ways to reduce exposure.
That might mean checking local drinking water reports, using certified water filters designed to reduce PFAS, and limiting the use of stain- or grease-resistant products when alternatives are available.
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Meaningful reductions in PFAS exposure will likely depend on broader regulatory action and environmental cleanup efforts, Li added.
The researchers noted that midlife could be a particularly sensitive stage, when the body is more susceptible to stressors associated with aging. (iStock)
Study limitations
The researchers outlined several important limitations of the research, including that the findings show an association, but do not prove that PFAS directly causes accelerated aging.
“The study is cross-sectional, meaning exposure and aging markers were measured at the same time, so we cannot determine causality,” Li told Fox News Digital.
The study was also relatively small, limited to 326 adults age 50 or older, which means the findings may not apply to younger people or broader populations.
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Researchers measured PFAS levels using data collected between 1999 and 2000, and today’s exposure patterns may differ.
Li added that while PFAS is known to persist in the environment and the body, these results should be validated through larger, more recent studies that follow participants over time.
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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.
The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.
Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.
The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)
“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release.
“Our new results uncovered new biology while also opening doors for new drug targets.”
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The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted.
“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said.
The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)
That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.
In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.
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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.
The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.
“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)
“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.
Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.
Limitations and caveats
The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.
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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.
Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.
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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”
“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”
The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.
It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.
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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.
Fox News Digital reached out to the drug manufacturer and the researchers for comment.
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