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.
For more Health articles, visit www.foxnews.com/health.
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Health
Common eating habit may trigger premature immune system aging, study finds
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Eating too much salt has long been linked to high blood pressure, but new research suggests it could trick the immune system into prematurely aging the blood vessels.
A preclinical study recently published in the Journal of the American Heart Association has identified a biological chain reaction that links a salty diet to cardiovascular decay.
Scientists at the University of South Alabama observed that mice on a high-salt diet experienced rapid deterioration in their blood vessel function.
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After just four weeks of high sodium intake, the small arteries responsible for regulating blood flow lost their ability to relax, according to a press release.
The team found that the cells lining these vessels had entered a state of cellular senescence, a form of premature cellular aging in which cells stop dividing and release a mix of inflammatory signals that can damage surrounding tissue.
Excess salt has long been linked to high blood pressure, but a new study goes deeper into its effects on the cardiovascular system. (iStock)
The researchers tried to replicate this damage by exposing blood vessel cells directly to salt in a laboratory dish, but the cells showed no harmful effects.
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This suggests that salt isn’t directly causing damage to the vascular lining but that the real culprit may be the body’s own defense mechanism, the researchers noted.
Excess salt may trigger the immune system to release a molecule called interleukin-16 (IL-16), which acts as a messenger that instructs blood vessel cells to grow old before their time, according to the study.
Excess salt may trigger the immune system to release a molecule called interleukin-16, which acts as a messenger that instructs blood vessel cells to grow old before their time, according to the study. (iStock)
Once these cells age, they fail to produce nitric oxide, the essential gas that tells arteries to dilate and stay flexible.
To test whether this process could be reversed, the team turned to a class of experimental drugs known as senolytics.
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Using a cancer medication called navitoclax, which selectively clears out aged and dysfunctional cells, the researchers were able to restore nearly normal blood vessel function in the salt-fed mice, the release stated.
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By removing the decaying cells created by the high-salt diet, the drug allowed the remaining healthy tissue to maintain its elasticity and respond correctly to blood flow demands.
Excess salt may trigger the immune system into stopping the cells from dividing, the study suggests. (iStock)
The study did have some limitations. The transition from mouse models to human treatment remains a significant hurdle, the team cautioned.
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Senolytic drugs like navitoclax are still being studied for safety, and the team emphasized that previous trials have shown mixed results regarding their impact on artery plaque.
Additionally, the researchers have not yet confirmed whether the same IL-16 pathway is the primary driver of vascular aging in humans.
Health
Healthy diets spark lung cancer risk in non-smokers as pesticides loom
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Eating a diet high in fruits and vegetables was found to have a surprising link to lung cancer among younger non-smokers, early research suggests.
The observational study, led by Jorge Nieva, M.D., of the USC Norris Comprehensive Cancer Center at Keck Medicine, was presented this month at the American Association for Cancer Research (AACR) annual meeting in San Diego. It has not yet been peer-reviewed.
Researchers looked at dietary, smoking and demographic data for 187 patients who were diagnosed with lung cancer at age 50 or younger.
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They found that among non-smokers, there was a link between healthier-than-average diets – rich in fruits, vegetables and whole grains – and the chance of lung cancer development.
Young lung cancer patients ate more servings of dark green vegetables, legumes and whole grains compared to the average U.S. adult, the researchers found.
Eating a diet high in fruits and vegetables was found to have a surprising link to lung cancer among younger non-smokers, early research suggests. (iStock)
The researchers hypothesized that pesticides applied to conventionally grown produce could be a possible factor in the disease association.
“Commercially produced (non-organic) fruits, vegetables and whole grains are more likely to be associated with a higher residue of pesticides than dairy, meat and many processed foods,” according to Nieva. He also noted that agricultural workers exposed to pesticides tend to have higher rates of lung cancer.
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“There is a large subset of lung cancer patients whose disease is not caused by smoking,” Nieva told Fox News Digital.
The disease is becoming more common in non-smokers 50 and younger, especially women – despite the fact that smoking rates have been falling for decades, the researcher noted.
The researchers hypothesized that pesticides applied to conventionally grown produce could be a possible factor in the disease association. (iStock)
“These patients tend to have eaten much healthier diets before their diagnosis than the average American,” he went on. “We need to support research into understanding why Americans – and women in particular – who no longer smoke very much are still having lung cancer,” he said.
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The study did have some limitations, Nieva acknowledged, primarily that it relied on survey data and was limited by the participants’ memories of their food intake.
“Also, the survey participants were self-selected, and this could have biased the findings,” he told Fox News Digital.
“There is a large subset of lung cancer patients whose disease is not caused by smoking.”
The researchers did not test specific foods for pesticides, relying instead on average pesticide levels for certain types of food. Looking ahead, they plan to test patients’ blood and urine samples to directly measure pesticide levels, Nieva said.
Although the study shows only an association and does not prove that pesticides caused lung cancer, Nieva recommends that people wash their produce before eating and choose organic foods whenever possible.
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“This work represents a critical step toward identifying modifiable environmental factors that may contribute to lung cancer in young adults,” said Nieva. “Our hope is that these insights can guide both public health recommendations and future investigation into lung cancer prevention.”
“It is possible that the increased lung cancer risk could be due to pesticide exposure in whole farmed foods, but is by no means certain,” a doctor said. (AP Photo/Charlie Neibergall)
Dr. Marc Siegel, Fox News senior medical analyst, said the study is “interesting,” but that it “raises far more questions than it answers.”
“It is a small study (around 150) and observational, so no proof,” the doctor, who was not involved in the research, told Fox News Digital.
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“It is possible that the increased lung cancer risk could be due to pesticide exposure in whole farmed foods, but it is by no means certain,” Siegel went on. “How much exposure is needed? How much of it gets into food and in which areas? This requires much further study.”
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Kayla Nichols, communications director for Pesticide Action & Agroecology Network, a distributed global network, said the organization agrees with the study’s conclusion that more research should be done on the rise in lung cancer, particularly in individuals eating diets higher in produce and fiber.
“There is a large subset of lung cancer patients whose disease is not caused by smoking,” the researcher told Fox News Digital. (iStock)
“There is a bounty of existing research that already links pesticide exposure to increased risk of multiple types of cancers,” Nichols, who was also not involved in the study, told Fox News Digital. She called for more research on chronic, low-level exposures to pesticides, as well as more effective policies to protect the public from pesticide residues on food.
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The study was supported by the National Institutes of Health and the National Cancer Institute, as well as industry partners including AstraZeneca and Genentech, among others.
Fox News Digital reached out to several pesticide companies and trade groups for comment.
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