"Pregnancy fluid" reverses ageing bones

Cells in the amniotic fluid that surrounds a developing baby can revive ageing and weak bones, say UK scientists.

The discovery could help babies with genetic diseases, elderly people and even astronauts, they say.

The findings in mice, published in Scientific Reports, showed cells in the fluid strengthened bone and cut fractures by 80%.

Human clinical trials are planned within the next two years.

Brittle bones

The amniotic fluid protects the baby and helps it develop inside the mother's womb.

It also contains stem cells that are the building blocks of other tissues.

The researchers collected the amniotic stem cells from material left over from screening tests during pregnancy or collected immediately before birth.

The team at the Institute of Child Health - a collaboration of Great Ormond Street Hospital and University College London - injected the cells into diseased mice.

The animals had brittle bone disease or osteogenesis imperfecta.

In people, the condition affects around one in every 25,000 births and can be fatal, with babies born with multiple fractures.

Even those who survive face up to 15 bone fractures a year, brittle teeth, impaired hearing and growth problems.

Tests on mice showed injecting the cells increased the strength, plasticity and structure of the animal's bones.

The number of fractures was cut to a fifth of their original level.

New bones

Dr Pascale Guillot, who conducted the research, said the findings could help people from crib to grave - from babies with brittle bone disease to pensioners with osteoporosis.

She told the BBC News website: "I am extremely excited because this is a major breakthrough that will potentially affect everyone.

"We are already used to putting cream on our face to slow down ageing of the skin, this will be the same for the skeleton.

"I think in the next few years we will have ways to slow down the ageing of our skeleton to reduce fractures and pain.

"This will also be very important for space travel as when you don't have G-force the bones become fragile."

Bone is constantly being remade with cells called osteoclasts breaking down old bone and osteoblasts making new bones.

Dr Guillot said brittle bone disease, osteoporosis and space travel were all characterised by osteoblasts "becoming lazy".

The study showed the stem cells were increasing the natural activity of the osteoblasts - rather than directly making new bone themselves.

"Stem cell transplants boost these lazy cells so they become very eager to make more bone and mature bone," added Dr Guillot.

Clinical trials are already planned, but ultimately the researchers' aim is to discover which chemicals the stem cells are releasing that kick the osteoblasts into gear.

Pregnancy alters woman's brain 'for at least two years

Pregnancy reduces grey matter in specific parts of a woman's brain, helping her bond with her baby and prepare for the demands of motherhood.

Scans of 25 first-time mums showed these structural brain chang

es lasted for at least two years after giving birth.

European researchers said the scale of brain changes during pregnancy were akin to those seen during adolescence.

But they found no evidence of women's memory deteriorating.

Many women have said they feel forgetful and emotional during pregnancy and put it down to "pregnancy" or "baby" brain - and, it seems, with good reason.

Hormone surge

Pregnancy is characterised by extreme surges of sex hormones and involves drastic physiological and physical changes in the body, the researchers say.

During those nine months, women experience a flood of oestrogen which is greater than for the whole of the rest of their lives.

Yet research on the effects of pregnancy on the human brain is scarce.

This study, from researchers at the Universitat Autonoma de Barcelona and Leiden University and published in Nature Neuroscience, looked at the brain scans of women before they became pregnant, soon after they gave birth, and two years later, to see how the brain changed.

And they compared these women's brains with those of 19 first-time fathers, 17 men without children and 20 women who had never given birth.

The researchers found "substantial" reductions in the volume of grey matter in the brains of first-time mothers.

The grey matter changes occurred in areas of the brain involved in social interactions used for attributing thoughts and feelings to other people - known as "theory-of-mind" tasks.

The researchers thought this would give new mothers an advantage in various ways - help them recognise the needs of their child, be more aware of potential social threats and become more attached to their baby.

Just by analysing the brain images, computers were able to pick out the women who had been pregnant.

Bonding with baby

In one task, women were shown pictures of their own babies and other babies and their brain activity was monitored.

The parts of the brain which lit up when they saw pictures of their own babies closely matched the areas where grey matter had been reduced or "fine-tuned" during pregnancy.

The same areas did not light up when pictures of other babies were viewed.

Elseline Hoekzema, study author and postdoctoral researcher at the Institute of Psychology at Leiden University in the Netherlands, said: "We can speculate that the volume reductions observed in pregnancy represent a process of specialisation or further maturation of this Theory of Mind network that, in some way, serves an adaptive purpose for pending motherhood."

The study found that pregnant women were all affected in similar ways, regardless of whether they conceived naturally or underwent IVF.

And there were no changes in first-time fathers' grey matter in the study when their brains were monitored before and after their partners' pregnancy.

The research team also found no major changes in white matter in the brain.

Mum gives birth to her own GRANDSON in surrogate baby joy after cancer left her daughter infertile

Julie Bradford, 45, offered her womb to her daughter Jess after she was left infertile by ovarian cancer at the age of just 18, and she says “any mother would do this for their child”

Devoted mum Julie Bradford has admitted nothing was going to stop her having a­­ ­surrogate baby for her cancer-stricken daughter.

The hairdresser, 45, bravely stood in for Jessica Jenkins, 21, after she was told she would never be able to have children.

Devastated Jessica opted to have her eggs frozen after becoming one of the youngest women in Britain to be diagnosed with cervical cancer when she was just 18.

Now, three years later, Julie has given birth to her baby grandson Jack.

Speaking to the Daily Mirror, proud Julie said: “Any mother would do this for their child. It was never in question from day one. He’s a Christmas miracle to us.

“You watch your daughter go through cancer at 18 and then say you would not do the same. But I would have done it anyway, it’s what mums do.

“If cancer couldn’t beat us there was no way I wasn’t having a baby for Jessica.”

And delighted Jessica said: “I cannot believe I’ve gone from facing death with cancer to facing my first Christmas with my son in just a few years.

“It just shows you how, no matter what life throws at you, you should never give up, because anything is possible.”

Jack — born last Friday at a healthy 6lb 10oz — may not have arrived if it was not for the quick thinking of doctors.

Jessica, of Rhymney, South Wales, had her eggs harvested on the day she started radiotherapy. She said: “The depth of despair was not getting cancer, you can beat cancer, the true depth was being told point blank I’d never have kids.

“But the doctors were ­brilliant, it usually takes at least four weeks to harvest eggs for IVF but they managed to do it in two.

“I had my eggs harvested in the morning, and started radiotherapy that afternoon.

“It was the last possible moment I could have started treatment. But it was such an immense feeling of relief to know that no matter what happened, I had done that because I had always longed to be a mum and couldn’t bear that being taken away.”

Jessica’s husband Rees Jenkins, 27, said being told the couple could never have children was a massive blow.

The machine setter fought back tears as he revealed: “The cancer I could deal with, it was horrible, but you knew there was hope. I’d never cried in front of Jess until the day she told me she could never have kids. We just sat in the car and bawled our eyes out.

“She said I should leave her, go my own way, I don’t think I’ve ever loved her more then I did in that moment.”

Much to the couple’s relief, Jessica soon battled back from cancer and has been in remission since October 2014.

And as soon as she got the all-clear, her devoted mum Julie stepped in to give her what she wanted most — a child.

Doctors had managed to take 21 eggs but only 10 had survived by the time they chose to go ahead with the IVF treatment earlier this year.

But despite her age and already having three children of her own, Julie said there was never any doubt she would help.

The mum, who went through the menopause at 38, continued: “We couldn’t control the cancer but we could control this so it was my way of taking control back for my daughter. I could do something incredible for Jessica and that’s what I was going to do, nothing was going to stop me.”

Incredibly, Julie learned she was ­pregnant on April 9 this year — two years to the day that Jessica was told she could never have children.

The pair have been inseparable ever since and talk lovingly of the moment Jessica felt Jack kick for the first time.

Wiping away tears, Jessica said: “We were hugging on the couch watching TV and Jack kicked me in the head. We both just cried our eyes out, it was the most amazing experience.

“My mum is my hero, she has shown me what true love means, I can never repay her for what she has done for us and the sacrifices she has made.”

The experience was not quite the same for Jack’s dad Rees.

He said: “I’ll admit at first it did freak me out that my son was being carried in my mum-in-law. I kept my distance respectfully a tiny little bit but as soon as she started showing, I thought I can’t keep my distance from this. It is the most amazing thing any person can do for another.

“Jess and her mum had a great ­relationship anyway but it’s only strengthened now.

“Seeing Jess and her mum crying with Jack in their arms will always be the greatest day of my life. I have not said thank you to Julie enough and I want her to know just how thankful I am, from the bottom of my heart.

“A few years ago I was in a cold medical room being informed Jess could die, then I was in a room welcoming our son into the world. It’s truly wonderful.”

Jessica was by her mother’s side throughout the three-and-a-half hour labour. Jessica said: “It was horrible watching my mum in pain, I felt really helpless but I held her hand and mopped her brow, she was truly incredible. The most incredible mum in the world.

Julie laughed: “I have had three so I did warn her what it would be like but I just got on with it.

“I had a bit of gas and air at the end but didn’t even touch a paracetamol.

“I was just so pleased to be able to bring my daughter’s child into the world, you don’t feel pain at times like that.”

Jessica also revealed she has not ruled out further children but will not ask Julie again. Instead she has her hopes set on pioneering womb transplant technology.

She said: “I couldn’t put mum through it again — I know they’re doing clinical trials on womb transplants in Switzerland — so the moment that comes over here I’m putting myself forward.”

And once again Julie has stepped in to help — by offering to donate her own womb for transplant.

Julie said: “I wouldn’t think twice. It’s clearly in working order isn’t.”

POSTHUMOUS SPERM SAMPLE: THE ISRAELI LEGAL SYSTEM INTERVENES

A 50 year-old Israeli couple have fought for the legal system to authorise posthumous sperm retrieval from their son who died in a car accident at the age of 25. They want to "give him the chance" to father a child because he wanted "a family". "Keen to become grandparents", they want to raise this child themselves.

In September, the Petah Tikva Family Court granted permission to the family to raise the child to be conceived from their son's sperm and purchased eggs. The family had decided to implant the eggs in the uterus of a surrogate mother. However, despite the decision given in September, the Court announced that the family should prepare for an appeal given the unusual circumstances of the case brought by this couple who want to be both parents and grandparents to their son's offspring. Pending a final decision, the Court has placed an injunction on the couple, banning them from using their deceased son’s sperm.

This case of posthumous sperm retrieval is the first of its kind in Israel. Since 2003, Israeli law has authorised the retrieval of posthumous sperm samples only for subsequent insemination or implantation by in-vitro fertilisation or for the deceased person’s wife to be inseminated. Some countries authorise posthumous sperm retrieval if the deceased has left written authorisation to this effect. It is prohibited in France, Germany and Sweden.

CAMBODIA FOLLOWS IN THE FOOTSTEPS OF INDIA AND THAILAND TO BAN SURROGACY

The Cambodian Ministry of Health has decided to ban recourse to surrogacy given the nationwide increase in this practice since surrogacy was banned in Thailand and India. Moreover, until now, the cost of surrogacy in Cambodia has been very low compared to the United States. In the absence of legislation, clinics accepted homosexual partners as well as single people.

Last week, the Cambodian Health Ministry sent a memo to clinics offering surrogacy services, stating the following: "There is a permanent ban on surrogacy", adding that, concerned about spin-offs, the government "is working towards legislation that will protect women and children from becoming objects of trafficking".

For Sam Everingham, founder of  Families Through Surrogacy, an association dedicated to surrogacy, access to Cambodian surrogate mothers represented "an industry that has rapidly developed in a country that was not prepared to face up to facts, particularly in terms of medical services". He added that the decision taken by the Cambodian Government "will spread panic amongst the numerous intended parents... just as we saw in Thailand".

Australian woman gets pregnant twice in 10 days

An Australian woman who was told she might never become pregnant says she has given birth to twins conceived 10 days apart.

Kate Hill was receiving hormone treatment for polycystic ovary syndrome, a condition that meant she was not ovulating.

She apparently conceived twins at different times d

espite only having unprotected sex once during that time.

It is very rare for a woman to conceive a second time when already pregnant.

Most twins are the result of a woman releasing two eggs at the same time, or, less commonly, a fertilised egg subsequently splitting into two.

The twin girls, Charlotte and Olivia, were born 10 months ago with different sizes, weights and gestational development, according to reports.

"We actually did not realise how special that was until they were born," Mrs Hill told Australia's Seven Network.

Pregnancy normally stops the monthly cycle of ovulation but very rarely a woman can release another egg after conceiving. If this is fertilised it could also implant and develop into a healthy pregnancy.

It is believed only 10 cases of the phenomenon, known as superfoetation, have been documented across the world.

Speaking about the rare conception, Mrs Hill's husband Peter joked: "Hole in one, maybe."

The couple's obstetrician Brad Armstrong said the condition was so rare he was forced to search for it online.

"I could not find any literature in the medical review websites at all," he said.

A MATERNAL BLOOD TEST COULD PREDICT PROBLEMS AT BIRTH

A protein circulating in the blood of pregnant women could be used to develop antenatal tests to determine the health of babies and predict the need for emergency care at birth, based on a study conducted by Queen Mary University London (QMUL).

The test conducted in mice and then in a cohort of 129 women, has shown that levels of the blood marker known as DLK1 are a good predictor of foetal growth and pregnancy-related complications. Scientists are considering using this marker as a non-invasive ante-natal screening tool but recommend further studies to consolidate their results.

 Doctor Marika Charalambous who led the study explained that this discovery could identify the causes of a small-sized foetus, clarifying whether this is due to a nutrient deficiency in the uterus or simply genetic factors. This precise information will allow obstetricians to plan for any complications on delivery.

 DLK1 is a protein that is found in large quantities in the mother's blood during pregnancy, in humans and rodents. However, its role has not yet been fully elucidated. The study -  financed by the Medical Research Council and published in the Nature Genetics Journal - has shown that this protein comes from the embryo. Concentrations in maternal milk could give a direct indication of the biological condition of the embryo.

Moreover, DLK1 levels have proved to be good indicators of foetal weight with low DLK1 levels being linked to reduced foetal growth.

Chinese medicine technique may offer some relief in perimenopause

A Chinese medicine technique using a smooth-edged instrument to scrape or rub certain areas of the body may relieve troublesome symptoms women experience in the years leading up to menopause, according to a new study.

Perimenopause can begin eight to 10 years before menopause, as estrogen levels fluctuate and start declining but menstrual cycles continue. During this time, and for another year or more after menstruation stops, women may experience hot flashes, insomnia, tiredness, mood swings, forgetfulness, aches and pains, vaginal dryness and pain during sex.

It's estimated that 75 percent to 92 percent of women going through perimenopause have at least some of these symptoms, and about 40 percent find them problematic enough to seek help, the study authors write in the journal Menopause.

Gua sha therapy is one of the most commonly used techniques in Traditional Chinese Medicine, they add, and it's thought to work by enhancing surface circulation and producing an antinflammatory effect.

"Gua sha therapy has been widely applied in clinical practice in China," said coauthor Pei-bei Duan of Jiangsu Province Hospital of Traditional Chinese Medicine in Nanjing.

Past studies have found it may prevent or treat many common and frequently-occurring conditions, such as acute or chronic pain, colds, flu, fever, heatstroke, asthma and emphysema, Duan told Reuters Health by email.

For the study, researchers recruited 80 women with perimenopausal symptoms from a clinic at the First Affiliated Hospital of Nanjing University of Chinese Medicine and divided them randomly into two groups.

One group received only conventional treatment, in this case drinking a liquid derived from traditional Chinese herbs called Qingxin Zishen Tang twice daily. The other group received the same conventional treatment plus weekly 15-minute Gua sha sessions, in which a therapist used a buffalo horn scraper and a skin lubricant to stimulate "acupoints" similar to those targeted by acupuncture focusing on the back, lower limbs and upper limbs for eight weeks.

Gua sha scraping causes red or purple marks on the skin which typically fade within seven days, the authors note.

After eight weeks, scores on a menopause-specific quality of life questionnaire had improved for both groups of women, but significantly more for the women in the Gua sha group. They also experienced greater reductions in hot flashes and sweating, insomnia, nervousness, melancholia, fatigue and headache than the comparison group receiving only conventional treatment.

The available studies on this topic are few and weak, said Dr. Francesco Cardini of the Health and Social Regional Agency in Emilia Romagna in Italy, who was not part of the new study.

"As with other traditional practices, Gua sha treatment, which creates superficial transitory skin lesions, may not be accepted by women with non Chinese culture," Cardini told Reuters Health by email.

"Gua sha therapy for perimenopausal symptoms was well tolerated by participants in our study," Duan said. "Only two transient and mild adverse events were reported and no serious adverse events occurred. Both were deemed unrelated to Gua sha. The two cases both had mild dizziness; one was caused by hypoglycemia because the patient did not eat breakfast, and another one was too nervous at the first treatment."

The long-term benefits of Gua sha therapy are not known, Duan said. Theoretically, women in China have access to this therapy, but only at large Traditional Chinese Medicine hospitals.

"Women who live in rural areas have to travel a long way to the cities to get the therapy, which is inconvenient," Duan said. "If women have the access to Gua sha therapy, they should try it."

In the U.S., some licensed massage therapists offer Gua sha therapy and it has been endorsed by celebrities like Gwyneth Paltrow.

Researchers develop new technique that measures speed of rotating semen

The maths of collective behavior has provided a new technique for selecting the best semen for artificial insemination in livestock.

In the world of artificial insemination, it is well known that the most active semen samples indicate strongly swimming sperm, and the most fertile males. The activity of the semen is currently ranked on a scale between one and five, but this is based on the subjective views of observers down a microscope.

Now, in an effort to quantify the ranking, researchers from Imperial College London, the University of Toulouse and the French National Institute for Agricultural Research, have developed a method that measures the speed of rotating semen.

The technique, and results of the study of semen motion, are published this month in the Journal of the Royal Society Interface.

Semen samples are usually ranked on the mass motility (MM) scale, based on how turbulent the churning of semen is in a drop on a microscope slide. The motion of sperm in the semen drop appears random, and observers assign the activity of this motion a number from one (lowest) to five (highest).

The team studied the motion of ram's semen to see if they could determine patterns that could be quickly mapped by computer, providing a more objective ranking. What they found was that if the semen was confined to a ring of plastic on the microscope slide, at a certain sperm concentration it would start to collectively rotate in one direction.

The spinning is faster according to the MM score, providing a simple measure that can be automatically assessed by computer.

It was not known previously that highly concentrated semen would behave this way, but there were clues from the animal kingdom. Professor Pierre Degond, from the Department of Mathematics at Imperial, studies the maths of mobs and collective behavior.

He said: "Experiments with locusts have shown that if you have just a few locusts, they will jump in random directions. But confine them and add enough locusts, then they will start to move coherently in the same direction, just like the sperm in our experiment."

Below a certain concentration threshold, the semen will behave in a more random way again, even when confined. Ram's semen is 50-100 times more concentrated than human semen, but Professor Degond thinks the same pattern would be observed if human semen were concentrated first. However, his next work is in how sperm swim once they are inside the female.

He said: "Fertility is a factor not just of how well the sperm swim, but how they interact with the female environment. They have to swim through a mucus rich in proteins that form a sort of mesh maze for them, and we want to study how they do this."

Women freeze eggs to gain time to find the right partners study finds

Women are choosing to freeze their eggs to gain time to find the right partner rather than to pursue their careers, new research suggests.

Based on interviews with 31 heterosexual women who had frozen their eggs for non-medical reasons, researchers discovered that the greatest motivation was because the women said they had not found the right man to father their child.

“Women weren’t engaging with technology for their career, they didn’t necessarily seek to delay, [or] put off motherhood, but it was very much more about they wanted to pursue motherhood at the right time, in the right way, with this right partner,” said lead researcher Kylie Baldwin, of the ReproductionResearch group at the UK’s De Montfort University.

“Women’s use of this technology is often driven by their relationships with men,” said Baldwin. “Instead of it being focused on egg freezing being a women’s concern, I think it needs to be broadened - I think men need to be brought into the picture more and there needs to be a more well-rounded understanding about why women engage with this technology.”

Emily Jackson, professor of law at the London School of Economics and a specialist in reproductive issues, said that despite coming from a small sample of women the findings were consistent with reports from the limited number of other studies available.

“[The findings don’t] mean [egg freezing] is not entirely unrelated to work, in the sense that the reason why one might find oneself 38 and single might have something to do with what career conditions were like in one’s 20s,” she said.

Egg freezing technology has taken off in the past five years or so, with increasing availability of a new approach, called vitrification, that has boosted success rates of conception.

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Tim Child, the medical director of the Oxford Fertility Unit, said that the findings chimed with his experience. “The majority of egg freezing requests are because someone wants to preserve their fertility so they feel as though if it is a few years before they meet the person they want to have a child with, and perhaps their fertility has declined to an extent where that might be more difficult to happen, at least they have got some fertility frozen in time,” he said.

Child also says that the sample size does not undermine the results. “You can base such studies on quite small numbers if the studies are conducted to a high standard.”

While the proportion of women freezing their eggs is still low, numbers are growing. According to the UK’s Human Fertilisation and Embryology Authority (HFEA), 816 British women underwent treatment to freeze their eggs in 2014, compared to 652 women in 2013. The approximate rate of live births using frozen eggs, based on those thawed in 2013, was 14%. Although, the report notes, “The success rate is affected by the age of the woman at the time her eggs were frozen and was considerably lower for women in the older age group.”

While the HFEA does not record detailed information on why the women chose to freeze their eggs, or the proportion who did so for medical reasons, in 2014 54.1% of those aged over 38 cited having no male partner as a reason, compared to 36.4% of those under the age of 38.

To delve into the issue, Baldwin interviewed women from the UK, US and Norway, recruited from advertisements, who said they had undergone egg freezing for non-medical reasons. Aged between 32 and 44 years old, all had been educated to degree level, with almost 40% having a postgraduate degree - a demographic typical of women who undertake such treatment, says Baldwin.

Baldwin says her results, which were presented at the British Science Festival on Wednesday, reveal that the primary reason why the women had opted to freeze their eggs was because they had yet to meet Mr Right.

“It wasn’t just about finding the right man, it was about finding the right potential father for their child,” she said. “They very much wanted to parent with their male partner who was committed to parenthood, who was going to perform that role of the hands-on father and would share the role of upbringing, the pleasures and pains of upbringing, equally.”

Other reasons, such as job instability or housing-related issues were also mentioned, says Baldwin, with 20% reporting an underlying health condition that contributed to their choice.

While several companies, including Apple and Facebook, offer egg freezing for female employees, Baldwin says she is not convinced by the approach. “Some of that use of egg freezing technology is often trying to solve the problem of older motherhood by not addressing the root cause, and the cause in many cases is this lack of a partner, lack of job security, not the desire to climb the career ladder,” she said.

With 37 as the average age of participants, the research reveals that women are leaving it until later in life to freeze their eggs, despite the decline in egg quality with age, says Baldwin. “Women need to be engaging with this technology for it to be the most effective before the age of 35, or perhaps even earlier,” she said.

But as Jackson points out, there are other considerations. Women in their early thirties still have a good chance of a natural pregnancy, she says, meaning that freezing eggs in their twenties could be an unnecessary invasive and expensive procedure. What’s more, in the absence of special circumstances, current legislation only allows eggs to be frozen for a maximum of 10 years. “The 10 year time limit means that in a sense it is not sensible to freeze them early, even thought that might be clinically sensible, because they won’t be available to you [later],” she said.

Baldwin also warns that the idea of egg freezing should not be presented to women as a quick fix. Cheryl Fitzgerald, Consultant in Reproductive Medicine at Old St Mary’s Hospital, Manchester, agrees. “I think seeing egg freezing as an option when it is things like you haven’t got your house or your haven’t got your job sorted is a really, really bad message because the majority of those women will then not end up with a baby,” she said. 

“Egg freezing is obviously great for those women who have no other option, but I think it shouldn’t be something that women resort to at an early stage. I think society needs to change and facilitate women to have their babies when they are younger.”

While Fitzgerald stresses that it is up to individuals to decide whether or not to freeze their eggs, she warns against the idea of viewing the technology as a simple solution.

“I think it is quite dangerous to start suggesting that, by medicalising a social problem, we can cure it,” she said. “If you’ve not met your partner, you’ve not met your partner, but I think it is a really bad message to give out that actually now we can get round this by egg freezing, because the majority of those women will still not have a baby.”

Episona unveils first innovative new male fertility test at ASRM 2016

Episona Inc., an epigenetics data company focused on improving outcomes in reproductive health, announced today the launch of Seed, an innovative new male fertility test, at the American Society for Reproductive Medicine Scientific Congress& Expo. Seedis the first product on the market to evaluate epigenetic changes on DNA to predict the risk for male factorinfertility and poor embryo development, offering physicians and their patients a valuable new tool for personalizing fertility treatment and increasing the chances of pregnancy sooner and more cost effectively. 

"Physicians have long relied on the traditional semen analysis as the sole option for determining the male's role in fertility," said Episona President and CEO Alan Horsager,Ph.D. "While semen analyses provide valuable information on sperm count, motility and morphology, they offer little insight into the more complex factors related to male fertility or into the male's role in embryo development. By combining the latest advances in science and technology, Seed provides patientswith previously missing information about their fertility and we believe this has the potential to transform fertility care."

Seed is a physician-ordered test offered in a simple fertility kit for use at home or in a fertility clinic. Samples are sent to a CLIA-certified lab for analysis. Within two weeks physicians receive a detailed two-part interactive report on the patient’s risk of male factor infertility and poor embryo development. Male factor risk can help identify the severity of a patient’s case, helping both the physician and patient understand whether they should spend time and money pursing less invasive procedures such as intrauterine insemination (IUI) or move directly to in vitro fertilization (IVF). By analyzing sperm’s role in embryo development, Seed results can help identify problems that might occur with IVF and provide some answers if an IVF cycle fails or, in the case of seeking a donor, whether a male or female donor would be preferred.

"Male factors contribute to about half of the cases of infertility in couples, yet testingoptions for men have been woefully lacking. What's more, about a quarter of infertility cases are unexplainable," said Dr. Richard T. Scott, Jr., a founding partner at Reproductive Medicine Associates of New Jersey, and an Episona scientific advisory board member. "Seed has the potential to provide my patients with the information needed to better guide their course of treatment. I look forward to bringing this new test to my practice and to helping my patients become pregnant sooner."

Seed's novel approach is based on the science of epigenetics. Epigenetics examines external or environmental factors such as aging, smoking, obesity, environmental exposure or even exercise thatcan cause changes to the layer on top of the DNA known as the epigenome. These modifications to the DNA alter how genes are expressed, or read, which in turn can impact how genes function. Episona focuses specifically on DNA methylationon the epigenome by looking at the differences in methylation between known fertile sperm DNA and infertile sperm DNA. Using microarrays from Illumina Inc., Seed examines over 480,000 regions on sperm DNA for abnormal methylation at different gene sites important to fertility. A relative risk is then assigned to each abnormal location for either male factor infertility or poor embryo development.

"The Seed test uses epigenetics, which allows us to look much more deeply at potential problems associated with impaired fertility in men,”said Dr. Paul Turek, an internationally known leader in men’s reproductive health and an Episona's scientific advisory board member.

Episona has evaluated Seed in two clinical studies, with both demonstrating clear correlations between epigenetic abnormalities and male factor infertility. The first was a retrospective study involving 127 IVF patients and 36 known-fertile controls. The results of this study were published in Fertility & Sterility in August 2015. The second study was prospective and involved more than 200 patients from multiple clinical centers and 96 know-fertile controls. Episona intends to submit these study results for publication in a peer-reviewed journal early next year.

Seed, Episona's first commercial product, is initially being launched in the United States as a laboratory-developed test. Episona estimates there are more than 1.2 million couples seeking fertility care each year in the United States alone. The worldwide fertility market is estimated at $30-40 billion by Harris Williams & Co.