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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Feeling lonely may take a toll on older adults’ memory — but it may not speed up cognitive decline, according to a new study.
Researchers from Colombia, Spain and Sweden analyzed data from more than 10,000 adults ages 65 to 94 across 12 European countries and found those who reported higher levels of loneliness did worse on memory tests at the start of the study, according to research published this month in the journal Aging & Mental Health.
Over a seven-year period, however, memory decline occurred at a similar rate regardless of how lonely participants felt.
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“The finding that loneliness significantly impacted memory, but not the speed of decline in memory over time was a surprising outcome,” lead author Dr. Luis Carlos Venegas-Sanabria of the School of Medicine and Health Sciences at the Universidad del Rosario said in a statement.
Loneliness may be linked to memory performance in older adults, a new study suggests. (iStock)
“It suggests that loneliness may play a more prominent role in the initial state of memory than in its progressive decline,” Venegas-Sanabria said, adding that the findings highlight the importance of addressing loneliness as a factor in cognitive performance.
The findings add to debate about whether loneliness contributes to dementia risk. While loneliness and social isolation are often considered risk factors for cognitive decline, research results have been mixed.
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The study looked at data from the long-running Survey of Health, Ageing and Retirement in Europe (SHARE), which tracked 10,217 older adults between 2012 and 2019. Participants were asked to recall words immediately and after a delay to measure memory performance.
Social isolation and loneliness could play a surprising role in cognitive health among seniors. (iStock)
Loneliness was assessed using three questions about how often participants felt isolated, left out or lacking companionship.
About 8% of participants reported high levels of loneliness at the outset. That group tended to be older, more likely to be female and more likely to have conditions such as depression.
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Researchers found that those with higher loneliness had lower scores on both immediate and delayed memory tests at baseline. Still, all groups — regardless of loneliness level — experienced similar declines in memory over time.
The results suggest loneliness may not directly accelerate the progression of memory loss, though it remains linked to poorer cognitive performance overall.
Researchers look at a brain scan at the National Institutes of Health in Bethesda, Maryland. (Saul Loeb/AFP/Getty Images)
Experts warn, however, that the findings should not be interpreted to mean loneliness is harmless.
“The finding that lonely older adults start with worse memory but don’t decline faster is actually the most interesting part of the paper, and I think it’s easy to misread,” said Jordan Weiss, Ph.D., a scientific advisor and aging expert at Assisted Living Magazine and a professor at NYU Grossman School of Medicine.
“It likely means loneliness does its damage earlier in life, well before people show up in a study like this at 65-plus,” Weiss told Fox News Digital.
By older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold, an aging expert says. (iStock)
He suggested that by older age, long-term social patterns may already be established, making it harder to detect when the effects of loneliness first took hold.
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“By the time you’re measuring someone in their late 60s, decades of social connection patterns are already baked in,” he said.
Weiss, who was not involved in the research, added that loneliness may coincide with other health conditions, and noted that participants who felt more isolated also had higher rates of depression, high-blood pressure and diabetes. The link, he said, may reflect a cluster of health risks rather than a direct cause.
“While they can go hand-in-hand, it’s not clear that loneliness contributes to dementia,” a psychotherapist says. (iStock)
Amy Morin, a Florida-based psychotherapist and author, said the findings reflect a broader pattern in research on loneliness and brain health, and that the relationship may be more complex than it appears.
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“The evidence shows there’s a link between loneliness and cognitive decline but there’s no direct evidence of a cause and effect relationship,” she said. “So while they can go hand-in-hand, it’s not clear that loneliness contributes to dementia.”
Morin added that loneliness, which can fluctuate, may not be the root of the problem, but rather a symptom of other underlying mental or physical health issues.
Researchers suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging. (iStock)
She said staying socially and mentally engaged is crucial for overall brain health.
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“It’s important to be proactive about social activities,” Morin said. “Joining a book club, having coffee with a friend, or attending faith-based services can be a powerful way to maintain connections in older age.”
The researchers also suggested screening for loneliness be incorporated into routine cognitive assessments as one way to support healthy aging.
Fox News Digital reached out to the researchers for comment.
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Research continues to uncover new details on how fasting may help extend life.
A new study published in the journal Nature Communications investigated how intermittent fasting can boost longevity in small worms often used in aging research.
Researchers from the University of Texas Southwestern Medical Center in Dallas compared worms that were fed normally to those that underwent a 24-hour fast in early adulthood and were then fed again, according to a press release.
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The scientists measured a variety of factors, including stored fat, gene activity related to fat metabolism and lifespan.
The results showed that the life-boosting benefit did not depend on the fasting itself but on the body’s behavior after eating again.
Experts say sustainability is key when choosing a long-term weight-loss strategy. (iStock)
Study lead Peter Douglas, associate professor of molecular biology and a member of the Hamon Center for Regenerative Science and Medicine at UT Southwestern, suggested that these discoveries “shift the focus toward a neglected side of the metabolic coin – the re-feeding phase.”
“Our data suggest that the health-promoting effects of intermittent fasting are not merely a product of the fast itself, but are dependent on how the metabolic machinery recalibrates during the subsequent transition back to a fed state,” he said.
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“Our findings bridge a gap between lipid metabolism and aging research,” he added. “By targeting aging, the single greatest risk factor for human disease, we move beyond treating isolated conditions toward a preventive model of medicine that enhances quality of life for all individuals.”
Lauri Wright, director of nutrition programs at the University of South Florida’s College of Public Health, called this a “high-quality” study that adds an “important nuance to how we think about fasting and longevity.”
Intermittent fasting typically involves limiting meals to an eight-hour daily window or fasting every other day. (iStock)
The benefits of the refeeding phase after fasting were “especially interesting,” Wright, who was not involved in the study, told Fox News Digital.
“The researchers showed that longevity was linked to the body’s ability to turn off fat breakdown after fasting, allowing cells to restore energy balance,” she reiterated.
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“From a scientific standpoint, that’s a meaningful shift because it suggests fasting is not just about burning fat, but about metabolic flexibility.”
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Fasting may support longevity through triggering metabolic switching, enhancing cellular repair and stress resistance and improving markers like insulin sensitivity, research shows.
Limitations and cautions
Although this study provides “important insight” on the power of refeeding, Wright noted that the findings should be approached with caution, as the study was done on worms and cannot always be translated to humans.
“Additionally, it explains how a process might work in a controlled lab condition rather than real-world eating behaviors,” she added as a limitation. “Finally, the study is short-term and doesn’t give us the long-term translation on lifespan outcomes.”
The review found intermittent fasting was barely more effective than doing nothing, according to the study authors. (iStock)
Wright cautioned that fasting is “not a magic solution for longevity, and how you eat overall matters more than when you eat.”
“I advise, first and foremost, to focus on diet quality, including a variety of fruits and vegetables, healthy fats and minimally processed foods,” she said.
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For those who are considering fasting, it’s better to stick with a moderate plan — like a 12- to 14-hour overnight fast — rather than going to extremes, Wright said. After fasting, she recommends focusing on well-balanced meals.
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Several groups of people should be cautioned against fasting, according to Wright, including those with diabetes who are on insulin or hypoglycemic medications, those who are pregnant or breastfeeding, anyone with a history of eating disorders and older adults at risk of malnutrition.
Anyone considering intermittent fasting should consult with a doctor before starting.
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