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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Just four minutes of daily strength exercises can dramatically improve mobility, balance and leg strength in older adults, per new research from the Penn State College of Medicine.
Standard public health guidelines recommend at least 150 minutes of moderate exercise per week. However, the study suggests that fewer than one in five older adults meet the recommended muscle-strengthening guidelines.
The research team designed a home-based program called Functional Activity Strength Training, or FAST-2. They evaluated 97 sedentary participants 65 and older, with an average age of 74.
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Before entering the study, these individuals were averaging just 18 minutes of total physical activity each week.
The older adults were randomly split into two groups, with one group performing the daily exercise routine and the other serving as a control group that received no intervention, according to the study’s press release.
Just four minutes of daily home strength training can significantly improve mobility, balance and leg strength in older adults, according to a Penn State College of Medicine study. (iStock)
Participants performed four basic movements for 30 seconds each, separated by 30-second rest intervals. The entire routine lasted exactly four minutes. The circuit consisted of push-ups, chair stands, two-arm resistance-band rows and stair stepping.
To keep the routine accessible, researchers provided written explanations and simple modifications. For example, participants could perform push-ups against a kitchen counter or wall, or use their hands on their knees for support during chair stands.
Participants were also given four elastic resistance bands and an adjustable step platform.
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“Exercise is actually really complicated, because you have to decide how many repetitions, how far, how many sets, how much rest and how many times per week,” co-author Smita Dandekar, associate professor of pediatrics at Penn State College of Medicine, said in the press release.
“It’s hard work … so if we can make it short, we’re part [of the] way there.”
The program consisted of four basic movements: push-ups, chair stands, resistance-band rows and stair stepping. (iStock)
As the participants grew stronger, they were encouraged to progress to higher levels of difficulty, such as transitioning away from modifications or increasing the height of the stepper.
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After 12 weeks, the results suggested that a tiny dose of regular exercise could yield noticeable physical benefits. In a 30-second chair-stand test, the exercise group performed an average of 4.2 more repetitions than the control group.
“These indicators … give you a sense of whether or not you’re going to be able to be active in the future.”
The adults doing the exercises also shaved 2.3 seconds off their time during a test measuring how they could stand up and sit down five times consecutively. Furthermore, they extended their one-legged balance time by an average of 3.6 seconds.
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The researchers emphasized that these specific measurements are critical medical indicators of an older adult’s future health.
By keeping the routine ultra-short, researchers eliminated common barriers like time constraints and exhaustion, resulting in an exceptionally high 81% workout completion rate. (iStock)
“These indicators predict your future ability to go into a nursing home, your future likelihood of falling and of developing difficulty walking,” noted lead author Christopher Sciamanna, professor of medicine and of public health at Penn State College of Medicine, in the press release.
“They give you a sense of whether or not you’re going to be able to be active in the future.”
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While traditional home exercise programs generally see low engagement, the participants in this study successfully completed their workouts on 81% of the tracked days, according to the researchers.
After 12 weeks, exercising seniors gained the ability to complete an average of four more chair-stand repetitions than those who did not exercise. (iStock)
The study had several noted limitations. As it tracked a relatively small sample size of fewer than 100 individuals over a brief 12-week time frame, it is unknown whether these mobility gains can be sustained long-term.
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Additionally, the researchers did not specify the exact dropout rates or detail how the routine might affect seniors who already relied on assistive devices like walkers or canes.
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Because the final trial results reflected a specific group of participants who met the entry criteria, further investigation is required to determine whether the short routine can safely benefit older adults facing more severe physical limitations or cognitive decline.
The study was published in the journal PLOS One.
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Jill Smokler, founder of Scary Mommy, has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer.
The popular “mommy blogger” had been fighting the disease for the past two years, according to an announcement posted on ScaryMommy.com on Monday.
The stay-at-home mother of three launched the blog in 2008 as a place to share the “joys and pitfalls” of parenting, according to the article.
As Scary Mommy expanded from a personal blog into a major parenting brand, Smokler built a following with her honest, often self-deprecating take on motherhood. She went on to speak at blogging conferences, author bestselling books, appear on national television programs and earn three Webby Awards, her biography states.
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“Jill spent her life telling the truth about motherhood — that it could be wonderful and impossible in the very same breath — and in doing so, she gave millions of women permission to stop pretending and feel a little less alone,” her family shared in a statement following her passing.
Jill Smokler, founder of Scary Mommy (pictured in 2018), has died at age 48 after a battle with glioblastoma, an aggressive form of brain cancer. (Lloyd Fox/Baltimore Sun/ZUMA Press Wire / Shutterstock)
“She was funny, fearless, generous and entirely herself. More than anything she built, Jill was proudest of her three children, Lily, Ben and Evan. We are heartbroken to lose her, and endlessly proud of the mark she left on the world.”
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Smokler’s first sign of the disease was in April 2024, when she experienced a sudden seizure. She then underwent surgery to remove a brain tumor, after which she didn’t recognize her own children, she previously shared with Today.
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“I am definitely grateful that I don’t remember the looks on their faces when I didn’t recognize them,” she said. “That must have been gutting.”
Smokler was diagnosed with glioblastoma, the most common malignant primary brain tumor in adults and one of the deadliest forms of brain cancer. There is currently no cure.
About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. (iStock)
Following surgery, the blogger underwent radiation and chemotherapy, during which she was open about her treatment side effects, including fatigue and hair loss. Additional surgeries and clinical trials followed, according to previous interviews.
“Thank you, Jill, for everything. May you rest in peace,” the Scary Mommy post concluded.
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About 13.9% of all brain tumors are glioblastomas, according to the American Brain Tumor Association. More than 12,000 new cases are diagnosed in the U.S. each year.
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Median survival is approximately 12 to 18 months after diagnosis, even with treatment. Only about 5% to 7% of patients survive five years after diagnosis, data shows.
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Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study.
Researchers analyzed data from 112,395 adults averaging 42 years of age, assessing their detailed dietary intake with an average follow-up of nearly eight years.
Among the participants, 5,544 developed hypertension during the follow-up period, and 2,450 experienced cardiovascular disease events.
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Higher consumption of total non-antioxidant preservatives was associated with a 29% greater risk of hypertension and a 16% higher risk of cardiovascular disease.
Higher consumption of total antioxidant preservatives was linked to a 22% spike in hypertension risk.
Common food preservatives may contribute to higher risks of high blood pressure and cardiovascular disease, according to a large French study. (iStock)
Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension, including the following.
- Potassium sorbate
- Sorbic acid
- Sodium nitrite
- Potassium nitrite
- Sodium metabisulphite
- Potassium metabisulphite
- Citric acid
- Tripotassium citrate
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Only one of the preservatives – ascorbic acid, which is the food additive form of vitamin C – was significantly associated with higher cardiovascular disease risk.
The finding does not mean that dietary vitamin C itself causes cardiovascular disease, the researchers noted. The study examined ascorbic acid in the form used as a food additive in processed foods, not vitamin C from fruits, vegetables or supplements.
Out of the 17 preservative additives consumed by at least 10% of participants, eight in particular were associated with higher rates of hypertension. (iStock)
The findings were published in the European Heart Journal.
“This is a very important study that puts together what we already know – that preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” Dr. Marc Siegel, Fox News senior medical analyst, told Fox News Digital.
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“Whereas potassium itself can lower blood pressure, the additive potassium sorbate has previously been found to be associated with hypertension in a large study in the European Heart Journal,” the doctor, who was not involved in the study, told Fox News Digital. “Potassium metabisulphite was also found to raise pressure in the same study.”
The same was found for sodium nitrite in the new study, Siegel noted, with 73% of participants consuming it regularly – “mostly in processed foods like hot dogs, ham, bacon and deli meats.”
“Preservatives of all kinds raise blood pressure and contribute directly to heart disease and stroke over eight years,” a doctor told Fox News Digital. (iStock)
“This has been found in previous research for many years,” he added.
Siegel also discussed the 22% increased risk linked to ascorbic acid. “I am dubious about this association, as it has not generally been found before, but perhaps the risk is when it is used as a chemical preservative.”
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“For all the sodium additives, this is expected, but surprising with extracts of rosemary and citric acid – the key to both of these ingredients is when they are used as preservatives (chemicals),” he added.
Potential limitations
As this was an observational study, it could not prove that the additives caused the health conditions.
Also, the participants who volunteered for the study were generally healthier, more educated and more often female than the general French population, the researchers noted.
As this was an observational study, it could not prove that the additives caused the health conditions. (FG Trade / Getty Images)
There was also the chance that hypertension was underdiagnosed in some participants.
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While the researchers estimated people’s dietary intake as accurately as possible, there was a chance that some consumption was inaccurately reported.
The authors emphasized that these findings need to be confirmed in further research of other populations.
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If the results are replicated in future research, some food preservatives may face additional safety reviews focused on their effects on the cardiovascular system, the researchers suggested.
“The take-home is to use natural ingredients as much as possible, and especially beware of sodium chemical preservatives when it comes to risk of heart disease and stroke from associated hypertension,” Siegel concluded.
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