Organon and Schering AG have announced that their research collaboration into a male hormonal contraceptive will conclude at the end of the phase II clinical trial.
Both companies described the collaboration as constructive, but came to the conclusion that the administration route investigated in the trial, which combined an annual implant with three-monthly injections, would unlikely result in a product that would be acceptable for widespread everyday use. Both companies remain committed to research in male contraception and will build on the knowledge gained from the collaboration to seek improvements in how such a contraceptive can be better administered.
The collaboration was announced in November 2002. The phase II trial which started in January 2004, was designed to test the reliability and acceptability of two hormones in combination which were known to have a suppressive effect on sperm production.
Commenting on the collaboration, David Nicholson, executive vice president, Global Research and Development, Organon, said: "The phase II trial was important as it showed that a progestogen combined with testosterone can work as a male contraceptive. Our next step is to find a way to make it easy to use and acceptable to the population.
Phil Smits, senior vice president, Global Business Unit Gynecology and Andrology, Schering, added: "For both Organon and Schering - as well as our clinical and scientific colleagues worldwide - this has been a long and demanding research program. However, we accept the challenge of developing what we have learned so far into a convenient contraceptive method for men. Male fertility control remains an important research area for Schering."
The trial medication and modes of administration were based on results from earlier studies showing that sperm production could be suppressed to contraceptive levels by the progestogen etonogestrel given as a subcutaneous implant, which was developed by Organon. While, at the same time, the resulting testosterone deficiency could be minimized with an injection of long-acting testosterone undecanoate, developed by Schering. Data from the trials will be jointly published upon final analysis.
Tuesday, September 26
Friday, September 8
Faculty's Siscovery Advances Infertility Research
Research on the DNA in the sperm of tiny soil worms sheds new light on the causes of human male infertility. Diana S. Chu, assistant professor of biology, is lead author on the paper, "Sperm Chromatin Proteomics Identifies Evolutionarily Conserved Fertility Factors," which identifies new proteins critical to the production of healthy sperm. Chu's cutting-edge research is the cover story of the Sept. 7 issue of the journal Nature.
Male infertility contributes to about 30 percent of reproductive failure in the United States. "Male fertility treatments go around the cause," Chu said. "No one knows the molecular basis of infertility ... how the proteins work." Her research concentrates on identifying these causes. The identification of the factors that function in fertility and reproduction could define new avenues for understanding human male infertility, finding appropriate treatments, and/or identifying male contraceptive methods.
Read More...
Male infertility contributes to about 30 percent of reproductive failure in the United States. "Male fertility treatments go around the cause," Chu said. "No one knows the molecular basis of infertility ... how the proteins work." Her research concentrates on identifying these causes. The identification of the factors that function in fertility and reproduction could define new avenues for understanding human male infertility, finding appropriate treatments, and/or identifying male contraceptive methods.
Read More...
Risky Business
Threat to fertility? Poor ergonomics? Possibility of fire? Laptop usage isn't without its potential hazards
If your neck hurts, or pecs feel particularly flabby today or if your crotch feels warm, turn off your laptop and put it aside for a moment.As hundreds of students head back to school and the ever-shrinking devices — now de rigueur for post-secondary and many secondary students — pop up in classroom and dorms, few people seem worried about the health hazards that intense use could bring. With 7 million laptops in use throughout the country, according to IDC Canada, which tracks technology trends, many Canadians, especially travelling businesspeople or those who use laptops as their main computer, are potentially doing their bodies harm.Most men might psychosomatically shudder to hear that a laptop, used in its most literal and seemingly innocuous way, balanced atop thighs in an airport lounge or bohemian coffeehouse, could affect their fertility.
Read More...
Thursday, September 7
Delaying Fatherhood Carries Risks, Studies Show
Biological clocks tick not only in women, but also for men fathering a child later in life, experts are finding.
It's not unusual to see men in their 50s and 60s starting new families. Men in their 80s can sire offspring.
"David Letterman, Charlie Chaplin — they had children at an older age," said Dr. Peter Chan, a urologist at the McGill University Health Centre in Montreal. "So that's the kind of mentality people have to think that it is OK to postpone fertility, which is fine except that they have to understand they're doing a bit of genetic gambling if they have children too late."
Having a high sperm count is no guarantee genetic material is free of age-related mutations.
Older fathers are at higher risk of producing children with physical malformations such as hemophilia and Duchenes muscular dystrophy, as well as mental disorders.
This week, one study suggested children born to men in their 50s are nine times more likely to develop autism than children born to men in their 20s or 30s.
Another study concluded men in their 50s are three times more likely to have a child that develops schizophrenia compared with those born to men in their 20s.
The problems can occur since sperm in a 50-year-old man may have gone through double or triple the number of cell divisions as sperm from a 20-year-old, said Chan.
"It's like making photocopies," he said. "The more copies you make, the lower the resolution and the lower the quality."
Researchers are beginning to understand more about the male biological clock.
They say there is no definitive answer on how old is "too old," but most sperm banks in North America won't accept donations from men older than 40.
CBC News
It's not unusual to see men in their 50s and 60s starting new families. Men in their 80s can sire offspring.
"David Letterman, Charlie Chaplin — they had children at an older age," said Dr. Peter Chan, a urologist at the McGill University Health Centre in Montreal. "So that's the kind of mentality people have to think that it is OK to postpone fertility, which is fine except that they have to understand they're doing a bit of genetic gambling if they have children too late."
Having a high sperm count is no guarantee genetic material is free of age-related mutations.
Older fathers are at higher risk of producing children with physical malformations such as hemophilia and Duchenes muscular dystrophy, as well as mental disorders.
This week, one study suggested children born to men in their 50s are nine times more likely to develop autism than children born to men in their 20s or 30s.
Another study concluded men in their 50s are three times more likely to have a child that develops schizophrenia compared with those born to men in their 20s.
The problems can occur since sperm in a 50-year-old man may have gone through double or triple the number of cell divisions as sperm from a 20-year-old, said Chan.
"It's like making photocopies," he said. "The more copies you make, the lower the resolution and the lower the quality."
Researchers are beginning to understand more about the male biological clock.
They say there is no definitive answer on how old is "too old," but most sperm banks in North America won't accept donations from men older than 40.
CBC News
Wednesday, September 6
Worm Sperm Gives Clue To Male Infertility
U.S. scientists say they have used the nematode worm to identify a raft of new proteins vital for healthy sperm production.
Barbara Meyer and colleagues at the University of California-Berkeley said the quality of sperm chromatin -- DNA packaged with associated proteins -- is known to be an important indicator of male fertility. Meyer's team wanted to identify proteins important for sperm chromatin structure.
They purified those proteins uniquely and richly associated with sperm chromatin in the worm Caenorhabditis elegans and tested their function using RNA interference of all 132 proteins identified.
The team found some were vital for DNA packaging, chromosome segregation and fertility.
In some cases, it's already known that disabling the equivalent proteins in mice causes male sterility. That list of proteins may help identify causes of and diagnostic tests for unexplained male infertility in humans or provide targets for male contraceptives.
Tuesday, September 5
Heated Seats In Cars Blamed For Low Male Fertility
Heated seats in cars may be more to blame for declining male fertility than tight trousers, a urologist warned Tuesday, two days before a German conference on men's illnesses. Herbert Sperling, who is to chair the meeting in Dusseldorf, said electrically heated seat covers, which are popular in wintry places, could reduce the growth of sperm.
Slow and mis-shapen sperm were also more common in drivers who spent long periods on hot seats.
"I think heated seats are a bigger risk than tight trousers," said Sperling, referring to common guidance that loose clothing may promote male fertility. The seats heated the temperature of the testicles to 38 degrees celsius, 3 degrees more than normal, he said.
Raw Story
Slow and mis-shapen sperm were also more common in drivers who spent long periods on hot seats.
"I think heated seats are a bigger risk than tight trousers," said Sperling, referring to common guidance that loose clothing may promote male fertility. The seats heated the temperature of the testicles to 38 degrees celsius, 3 degrees more than normal, he said.
Raw Story
Monday, September 4
Extra Weight Tied To Male Infertility In New Study
Gentlemen, here's one more reason to stay slim: Packing on extra pounds may increase the risk of male infertility, a new study says.
The preliminary research, conducted at the National Institute of Environmental Health Sciences, finds that the heavier one group of men became, the greater their chances of fertility woes.
That's sobering news in a country confronting an obesity epidemic.
"We know more and more men have become overweight but no one has looked at this fertility issue before," said Donna Day Baird, a National Institute of Environmental Health Sciences researcher involved with the study.
Baird's team didn't actually set out to explore the topic. But while mining data on the health of a large group of North Carolina and Iowa farmers, they spotted signs of fertility problems.
When they sorted the men by weight, the frequency of infertility rose along with heft. A 20-pound increase in men's weight correlated to a 10 percent increase in infertility, meaning the men and their wives failed to get pregnant after 12 months of trying.
Researchers screened out couples where the wives were 40 or older, since fertility in women declines sharply in those years.
The results are published in the September issue of the journal Epidemiol- ogy.
Before public health alarms get sounded, Baird said, she wants to confirm the findings in additional groups of men, a project she has started with data collected in Norway. If the findings hold, researchers should also inquire whether losing weight diminishes the risk of infertility among men.
"The little bit of research that exists on women suggests that is the case. It would be my hypothesis that would be true for men too," Baird said.
Multiple questions concerning male infertility linger already. Recent federal estimates say about 9 percent of married couples trying to conceive encounter infertility problems.
Research attributes at least 25 percent of the difficulty to men. But treatment of male infertility works only once every five times, as opposed to 80 percent of the time for women.
This new infertility study doesn't answer why overweight men may lean toward fertility problems. But earlier research has shown that overweight men can have reduced sperm counts, for instance, and lower testosterone levels.
It could also be that overweight men have less sex. Research at Duke University two years ago showed that men and women seeking treatment for obesity experience more sexual impairments than people outside treatment.
In that study involving a group of 506 weight-loss patients, 41 percent said they either didn't enjoy sexual activity, had no sexual desire, experienced difficulty with sexual performance or avoided sex. Only 5 percent of people with normal weigh reported the same.
The good news is that more research shows that even moderate weight loss can reduce those difficulties.
Catherine Clabby
The preliminary research, conducted at the National Institute of Environmental Health Sciences, finds that the heavier one group of men became, the greater their chances of fertility woes.
That's sobering news in a country confronting an obesity epidemic.
"We know more and more men have become overweight but no one has looked at this fertility issue before," said Donna Day Baird, a National Institute of Environmental Health Sciences researcher involved with the study.
Baird's team didn't actually set out to explore the topic. But while mining data on the health of a large group of North Carolina and Iowa farmers, they spotted signs of fertility problems.
When they sorted the men by weight, the frequency of infertility rose along with heft. A 20-pound increase in men's weight correlated to a 10 percent increase in infertility, meaning the men and their wives failed to get pregnant after 12 months of trying.
Researchers screened out couples where the wives were 40 or older, since fertility in women declines sharply in those years.
The results are published in the September issue of the journal Epidemiol- ogy.
Before public health alarms get sounded, Baird said, she wants to confirm the findings in additional groups of men, a project she has started with data collected in Norway. If the findings hold, researchers should also inquire whether losing weight diminishes the risk of infertility among men.
"The little bit of research that exists on women suggests that is the case. It would be my hypothesis that would be true for men too," Baird said.
Multiple questions concerning male infertility linger already. Recent federal estimates say about 9 percent of married couples trying to conceive encounter infertility problems.
Research attributes at least 25 percent of the difficulty to men. But treatment of male infertility works only once every five times, as opposed to 80 percent of the time for women.
This new infertility study doesn't answer why overweight men may lean toward fertility problems. But earlier research has shown that overweight men can have reduced sperm counts, for instance, and lower testosterone levels.
It could also be that overweight men have less sex. Research at Duke University two years ago showed that men and women seeking treatment for obesity experience more sexual impairments than people outside treatment.
In that study involving a group of 506 weight-loss patients, 41 percent said they either didn't enjoy sexual activity, had no sexual desire, experienced difficulty with sexual performance or avoided sex. Only 5 percent of people with normal weigh reported the same.
The good news is that more research shows that even moderate weight loss can reduce those difficulties.
Catherine Clabby
Saturday, September 2
Male Infertility May Have Obesity Link
New research shows a possible link between male infertility and obesity. The link -- based on male BMI (body mass index, which relates height to weight) -- hasn’t been proven and needs further study, the researchers stress. “To our knowledge this was the first study to examine male BMI and couple fertility. Thus, it is important that the findings will be confirmed or refuted in future studies,” researcher Markku Sallmen, PhD, tells WebMD in an email. Sallmen worked on the study while at the U.S. National Institute of Environmental Health Sciences and is now based at the Finnish Institute of Occupational Health in Helsinki, Finland. The study appears in Epidemiology’s September edition. Complex Issue
It’s often hard to pin down the source of infertility. Men and women may each have risk factors for infertility. For instance, women may have a harder time conceiving as they near the end of their childbearing years. Also, “it is well documented that women who are overweight or obese are at higher risk of reproductive problems, including reduced fertility,” the researchers write. But little has been known about what effect, if any, men’s BMI has on infertility, Sallmen’s team notes. Sallmen and colleagues studied 2,111 couples in Iowa and North Carolina. The men in those couples were mainly farmers; their wives were less than 40 years old. The researchers asked the men’s wives about infertility, defined as not conceiving a pregnancy after at least 12 months of unprotected sex in the previous four years, even if the wives later got pregnant. The husbands and wives reported their height and weight. The researchers used that data to calculate BMI. The couples didn’t get checkups or infertility tests for the study. But the researchers noted factors including the wives’ BMI and the age, smoking status, alcohol use, and exposure to solvents and pesticides for husbands and wives. Study’s Findings Compared with men with normal BMI of 20-22, those who had a three-point increase in BMI were 10 percent more likely to be a partner in an infertile couple during the four-year study period. “The results were the same when we limited the analysis to couples with female BMI of less than 26,” Sallmen tells WebMD. “I think that this finding offers further support for the idea that men's BMI is an independent risk factor for infertility,” Sallmen adds. However, the study has limits. For example, Sallmen’s team doesn’t know how often the couples had sex. It’s possible, but not certain, that heavier men had sex less often. Also, the data don't show if BMI changed over time for the husbands or wives. And about 30% of the husbands didn’t provide full information for BMI calculations. 'Plausible' but Not Proven “It is biologically plausible for high male BMI to increase the risk of infertility,” the researchers write. However, they write that their findings “must be viewed as supportive but not confirmatory of an association given the limitations of the study data." In other words, don’t count on the findings being correct unless other studies back up the results. If confirmed, the findings suggest that some cases of male infertility may be “an additional price associated with obesity epidemic,” write Sallmen and colleagues.
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