Reproductive Medicine Archive

Tuesday, November 3, 2009

24sure All Chromosome Testing for IVF Procedures

Dr. Steven Palter is reporting that at the latest meeting of the American Society for Reproductive Medicine, clinicians from Kenigsberg Reprogenetics in Livingston, NJ and Long Island IVF, in Melville, New York have presented results of a quick screening test that detects chromosomal aneuploidy (an abnormal number of chromosomes) in pre-implantation embryos. The chip technology from BlueGnome of Cambridge, UK is fast enough to be applicable for IVF procedures, and is apparently already being marketed to fertility clinics.

From Dr Palter's docinthemachine:

The new research presented: 6/55 tested embryos did not yield results (10.9%). 59% were abnormal One embryo classified by the new methods as normal had a trisomy 22 by FISH ( 5% false negative rate). 2 teed abnortmal were normal by FISH ( 7% false positive rate). The total error rate for full chromosome abnormalities was (6%). Overall aCGH seems to detect about 20% more abnormal embryos than FISH with a 6% error for full chromosome abnormalities.
Conclusions: this is a major technological step towards a more accurate and usable genetic method of testing embryos to improve pregnancy rates and reduce miscarriage rates. While some still feel that the test is too early to be reliable it is being introduced clinically and centers are beginning to use it. It is one of the only methods to test all chromosomes in an embryo and be able to put them back in the same cycle. As the technology improves the 6% error rate will decrease. More importantly the very wrapped up turnaround which is now less than 12 hours should allow the testing of multiple cells and allow a more accurate confirmation of the embryos true genetic nature. Techniques like this, we hope will be able to begin to identify healthy embryos and transform the practice of fertility treatment through technology.

Read on at docinthemachine...

Abstract: VALIDATION OF MICROARRAY CGH FOR PGD BY FISH REANALYSIS...

Product page: 24sure ...

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Friday, August 14, 2009

New Gel May Serve As Invisible Female Condom

Researchers from the University of Utah and Northwestern University have been studying an innovative new gel that may serve as a molecular female condom capable of blocking HIV and other pathogens from passing through. The gel solidifies when the vaginal environment's pH level changes to more basic, as when semen is introduced, thus creating a physical mesh barrier with pores down to 30 nanometers in size, smaller than most viruses can pass through. The researchers hope that the new material may one day provide women with a discreet way to protect themselves from pregnancy and venereal diseases.

In 2006, Kiser and colleagues published a study on their development of another "molecular condom" to be applied vaginally as a liquid, turn into a gel coating at body temperature, then, in the presence of semen, turn liquid and release an anti-HIV drug.
Unfortunately, few antiviral drugs bind to and attack HIV in semen. And in Africa, high air temperatures prevent the gel from turning liquid so it could coat the vagina evenly, Kiser says.

The new "molecular condom" gel in the current study works in the opposite way. Like the old version, it changes in response to changes in pH - acidity or alkalinity - in the vagina caused by the introduction of semen during sex. But unlike the old gel, which became liquid at the higher (less acidic) pH of semen, the new "molecular condom" becomes a semisolid at the pH of semen, forming a mesh of "crosslinked" molecules.

The new gel is applied as a gel, and then becomes more solid and impenetrable as changes in pH alter the strength of the bond between the gel's two key components, both of which are polymers, or long, chain-like molecules made of many smaller, repeating units: PBA, or phenylboronic acid, and SHA, or salicylhydroxamic acid.

The chemical bonds between the two polymers constantly attach and detach at normal, acidic vaginal pHs of about 4.8, allowing the gel to flow, Kiser says. But at a pH of 7.6 - the slightly alkaline condition when semen enters the vagina - the PBA and SHA polymers "crosslink" and stick tightly together, he adds.

Part of the new study characterized the flow of the gel.

"It flows at a vaginal pH, and the flow becomes slower and slower as pH increases, and it begins to act more solid at the pH of semen," Jay says. HIV moves slowly within the gel, even when the gel is at lower pHs (higher acidity) and still flowing, but the virus is blocked at higher pHs caused by the entry of semen into the vagina.

The crosslinked polymers form a mesh that is smaller than microscopic, and instead is nanoscopic - on the scale of atoms and molecules - with a mesh size of a mere 30 to 50 nanometers - or 30 to 50 billionths of a meter.

The gel also could help prevent AIDS by blocking movement of immune system cells that try to combat infectious agents but instead get hijacked by the AIDS virus.

Press release: An HIV-Blocking Gel for Women ...

Abstract in Advanced Functional Materials: Modulation of Viscoelasticity and HIV Transport as a Function of pH in a Reversibly Crosslinked Hydrogel

(hat tip: NewScientist)

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Monday, July 13, 2009

EmbryoScope Gets EU Green Light

Unisense FertiliTech A/S out of Aarhus, Denmark won European approval for the EmbryoScope™ Embryo Monitoring System. Using Leica optics and high quality filtration of the air technology, the instrument provides continuous control and recording of embryo development in a completely stable environment.

Features from the product page:

Six disposable EmbryoSlide™ trays holding 12 embryos each Individual slides may be inserted and removed independently
Leica 20 x 0.40 LWD Hoffman Modulation contrast objective specialized for 635 nm illumination 1280 × 1024 pixels, 3 pixels per μm, monochrome, 8-bit < 0.5 s per image, using single 1W red LED (635 nm)

20 min cycle time for six slides, 5 min cycle possible with single slide

Intel Core duo T2300E 1.66 Ghz 2Gb ram, fanless embedded PC

Microsoft Vista Pro®

12.1” embedded touch screen 1024 × 600

Continuous internal system integrity check of separate subsystems of the instrument as an added safety feature.

Press release: Unisense FertiliTech A/S Receives CE Mark of Approval for EmbryoScope(TM) Embryo Monitoring System...

Product page: EmbryoScope™ Embryo Monitoring System...

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Wednesday, July 8, 2009

Minimally Invasive Adiana Contraception Device Gets US Approval

Hologic out of Bedford, Massachusetts won FDA approval for the Adiana® permanent contraception system. The device first delivers RF energy to provoke a minimal inflammation inside section of the fallopian tube. Next, the clinician has to place a tiny stopper to block the passage. After placement, tissue forms around the stopper and permanently prevents future pregnancies.

The Adiana permanent contraception procedure is minimally invasive, requires no incisions and can be performed in the comfort of the doctor's office using local anesthesia. Patients are normally able to return to work or resume their daily activities within one day. In contrast, traditional methods of permanent contraception, such as tubal ligation, require more invasive surgical procedures, usually are conducted in a hospital under general anesthesia and typically require four to five days of recovery. As a result, these more invasive surgical procedures can pose serious risk of complications, including anesthesia-related problems and damage to organs or blood vessels. There were approximately 70,000 female transcervical contraception procedures performed in the U.S. last year.1

The Adiana procedure is indicated for women who desire permanent birth control by occlusion of the fallopian tubes. Ideal candidates include women who do not want children in the future and would like the peace of mind and convenience of permanent birth control. The procedure may also be an ideal solution for women who desire permanent birth control but are poor candidates for surgery.

Company video presenting the Adiana system:

Press release: FDA Approves Hologic's Adiana® Permanent Contraception System...

Product page: Adiana Permanent Contraception...

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Tuesday, June 30, 2009

Guardia Pro Helps Embryo Placement Through Assisted Reproductive Technology

Cook Medical has announced a unique new catheter for helping move embryos into the uterus through cervical mucus and blood. The Guardia Pro Protective Embryo Transfer Catheter makes cervical flushing or aspiration unnecessary prior to embryo placement.

From the press release:

The Guardia Pro's outer sheath protects the embryo through entry and then opens in petals to further advance the inner transfer catheter allowing placement of the embryo in the uterine cavity.
Additionally, the transfer catheter also incorporates Cook's Microvol™ technology that decreases the volume of fluid required for embryo transfer helping lessen the likelihood of embryo migration and allowing more accurate embryo placement.

Press release: Cook Medical Introduces the Guardia™ Pro Protective Embryo Transfer Catheter...

Product page: Guardia™ Pro Protective Embryo Transfer Catheter...

Product brochure...

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Friday, March 13, 2009

FC2 Female Condom Wins US OK

The FDA has given approval to the Female Health Company, out of Chicago, Illinois, to market the new FC2 female condom. The FC2 is made out of nitrile, a synthetic rubber compound, and promises considerable savings over previous female condoms.

FHC’s first-generation FC Female Condom® (FC1) originally received FDA approval for distribution in the United States in 1993. FC1 is also included in the World Health Organization’s (WHO) essential products list for distribution by United Nations (UN) agencies. Since its approval, 165 million FC1 female condoms have been distributed in 142 countries.
The cost of FC1 has remained a key barrier to increased uptake by HIV prevention programs in the U.S. and globally. While numerous studies over the past two decades have indicated that acceptability of FC1 is comparable to the male condom among both male and female users, the high cost of FC1 has limited procurement by government programs and direct purchase by individual consumers.

As a result, five years ago FHC initiated the development of the FC2 Female Condom to expand access to women at risk of HIV and STIs by significantly lowering the cost of the product. FHC has succeeded in reducing FC2’s cost through the introduction of a new material and a different manufacturing process. FC1 is made from polyurethane and involves a labor-intensive manufacturing process, while FC2, which looks very similar to FC1, is made from a proprietary nitrile polymer that allows it to be manufactured using a highly automated process. Studies have shown that FC2 performs in a comparable manner to FC1.

As a result of FHC’s development program, FC2 will be available to the public sector at a cost as much as 30 percent less than FC1, contingent on volumes of procurement. In addition, the company has indicated that as public sector volume increases, additional cost reductions may be possible.

Press release: Female Health Company Receives FDA Approval for FC2 Female Condom (PDF)

Product brochure (PDF)...

Flashback: New Female Condom to Face FDA Gavel

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Wednesday, January 21, 2009

Raman Spectroscopy to Aid in Selecting Viable Sperm for IVF

MIT Technology Review is reporting on the work of Alistair Elfick and colleagues at the University of Edinburgh that uses lasers to detect structural inconsistencies in the DNA of sperm. By applying Raman spectroscopy, a technique that identifies molecules by the way they scatter photons, the new technology may lead to better sperm selection methods during IVF.

From MIT Tech Review:

In order to probe a single sperm cell with Raman spectroscopy, the researchers first pin it down with optical tweezers--a focused laser beam that is able to "trap" a small object like a living cell. The unique scattering produced by each molecule creates a fingerprint of the contents in a sample, allowing scientists to analyze its chemical makeup. In this application, the researchers use Raman spectroscopy to look at the structure of a sperm cell's DNA and determine whether that DNA is broken or intact. Elfick explains that when DNA breaks, a chemical group forms at the ends of the breaks, and they can be detected with Raman spectroscopy.
Preliminary tests suggest that the technique does not harm the cells, although Elfick says that more rigorous testing must be done in order to bring the technique into clinical use. His team is hoping to commercialize this and other applications for Raman spectroscopy, including analyzing breast-cancer cells for specific proteins in order to tailor chemotherapy to individual patients.

Wednesday, December 10, 2008

New Female Condom to Face FDA Gavel

A new female condom, made out of a new synthetic rubber called nitrile by Female Health Co. out of Chicago, Illinois, is about to receive a judgment from an FDA advisory panel, potentially clearing it for approval.

Reuters reports:

The FC2 Female Condom, made by Female Health Co, is made with a synthetic rubber using a process similar to male condoms that the company says is less labor intensive and should reduce its current cost...
But FDA regulatory staff questioned whether the company should have conducted specific trials to show how well the FC2 prevents women from contracting diseases or becoming pregnant.

Female Health said it did not conduct such studies because FC2 uses a new material but is otherwise similar to the version already on the U.S. market, the FDA staff said in documents released on Tuesday ahead of the panel meeting.

Wednesday, December 3, 2008

Polyandry...Males May Not Need To Take All The Heat For "Bad" Behavior

Recently we have been reporting on the negative ramifications that testosterone appears to have on various aspects of male behavior such as stock-trading, war-making and promiscuity. A study released in the November 21st edition of Science shows that it's not just males that are up to no good! Female promiscuity encourages "sperm cocktails" which may lead to competition among the "swimmers". But, could other evolutionary pressures be involved in having multiple male partners, also known as polyandry?

The new research shows that it may be that males are also driving their partners to infidelity,at least on an evolutionary time-scale, and as it applies to fruit flies. The evidence shows that male "selfish" sperm may selectively attack XY sperm to select for female progeny, and, it appears, the female's defense to that "attack" is to seek multiple partners.

Science Online reports:

"Selfish" genes break the 50-50 inheritance rule by being passed onto offspring more often than not. Selfish genes "fight" other genes to get passed on to the next generation, often harming the carrier by causing problems such as reduced fertility. For example, male fruit flies can carry a selfish gene that destroys all of their sperm with a Y chromosome, so they produce fewer sperm and can father only daughters. Yet, male fruit flies with the selfish gene are physically identical to those without it.
To test whether females might evolve polyandry in response to the gene, the researchers ran an evolutionary experiment. They compared mating behavior between four fruit fly lines in which the selfish gene was present in about 30% of the males, and eight fruit fly lines lacking the gene entirely. Females in all the fruit fly lines showed nearly identical mating rates at the outset of the experiment. But after 10 generations, females from the selfish gene population remated, on average, almost a full day sooner than females from the populations without the selfish gene, the researchers report today in Science (p. 1241).

Remating increased the females' chances of snagging a male fly with normal fertility, the researchers note. The findings present a new explanation for polyandry: that it represents an attempt to prevent the spread of selfish genes, Wedell says. "I suspect this may be more general [than just flies] simply because selfish genes are ubiquitous."

Carol Boggs, an evolutionary ecologist at Stanford University in Palo Alto, California, says the work makes an important contribution to our understanding of how mating systems evolve. It's the first study to look at the potential impact of selfish genes on mating systems, she says. "This is something that could very well be a factor in the determining the evolution of polyandry."

We'll have to wait until Judge Judy rules on the science, but it certainly looks like the blame for infidelity in both sexes is being squarely placed on the male!

Science Online: Why the Lady is a Tramp

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Monday, November 24, 2008

Vacuum Erection Pumps + PDE5i Medications = A Pleasant Combination

Augmenting PDE5i treatments (i.e. Viagra® or Cialis®) with TIMM Medical Tech's ErecAid® vacuum erection device can greatly improve patient satisfaction, according to a new study lead by Dr. Arthur Burnett, Professor of Urology at Johns Hopkins School of Medicine.

Burnett says that the study "confirms an earlier trial that many patients can achieve excellent results using ErecAid(R) as an addition to oral PDE5i therapy. Based upon these results, I would encourage physicians treating ED to consider the importance of this approach in their treatment protocols and to discuss this option with their patients."

From the press release:

The phosphodiesterase five inhibitors (PDE5i) such as Viagra(R) and Cialis(R) have become a major resource in the management of ED. Unfortunately, 30-50% of men report inadequate results with these oral medications. When patients fail to respond to the oral medications, physicians are often forced to consider more invasive and more complicated second line agents such as penile injections or urethral suppositories.
Investigators at four separate study sites evaluated 69 men aged 36 to 82 with ED of diverse etiology who had responded inadequately to PDE5i therapy. Study subjects were allowed to continue use of PDE5i's but were instructed to use the ErecAid(R) device as an adjunct to their current oral medication. Study subjects were assessed using three validated measurements of erectile function and sexual satisfaction: the International Index of Erectile Function (IIEF-5), the Sexual Encounter Profile (SEP-2 and SEP-3) and the Global Patient Assessment Scale (GAPS).

After 4 weeks of supplemental treatment with ErecAid(R), the IIEF-5 score improved substantially from a baseline of 9.0 to 17.6 (p<0.001). Moreover, of the 34 subjects unable to achieve an erection satisfactory for intercourse at baseline (SEP-2 response of "no"), 27 subjects (79%) reported erections satisfactory for intercourse following the addition of ErecAid(R) (p<0.001). Finally, of 42 subjects reporting no or slight response to PDE5i at baseline (GAPS responses of "not at all" or "slightly"), 31 (74%) reported moderate or great improvement (GAPS responses of "moderately" or "greatly") at the end of the 4 week study (p<0.001).

Product page: Osbon ErecAid Vacuum Therapy System...

Press release...

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Wednesday, August 6, 2008

The ShangRing Circumcision Device

A device invented by Jianzhong Shang, a Chinese inventor from Wuhu City, is poised to become not only a new generation mohel-assist device, but a major medgadget in the world wide fight to prevent HIV.

Clinicians from NewYork-Presbyterian Hospital/Weill Cornell Medical Center are studying the two-ring device to see its efficacy and applicability for the African population and beyond.

From the NewYork-Presbyterian Hospital/Weill Cornell Medical Center press release:

With the recent endorsement by the World Health Organization (WHO) and scientists worldwide of adult male circumcision as an important strategy for HIV prevention, there is increased urgency to develop safe and cost-effective circumcision services. This is especially the case in Africa where HIV/AIDS continues to spread at an epidemic rate.
Studying this method are Dr. Marc Goldstein and physician-scientists at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, who are evaluating an innovative circumcision device developed in China and will initiate a study of the device in Africa in the coming months.

The device, named the ShangRing after its inventor, Mr. Jian-Zhong Shang, consists of two concentric plastic rings that sandwich the foreskin, allowing it to be cut away without suturing and with minimal bleeding. Performed in a clinic under local anesthesia, the procedure takes less than five minutes, compared with approximately 20 to 30 minutes for a traditional "free hands" circumcision that requires suturing. The patient returns in one week for device removal.

"Circumcision with this technique promises to be faster, safer and more acceptable to patients than conventional surgical circumcision methods," says Dr. Goldstein, the study's principal investigator. He is urologist and specialist in reproductive medicine at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, the Matthew P. Hardy Distinguished Professor of Reproductive Medicine and Urology at Weill Cornell Medical College, and senior scientist at The Population Council, Center for Biomedical Research, located on the campus of The Rockefeller University.

The ShangRing has been used to circumcise several thousand Chinese men since 2005. Preliminary reports of 1,200 patients indicate good results with minimal complications. The ShangRing, with 15 patents pending in 85 countries, is currently available only in China. FDA evaluation is under way.

We tried to obtain images of this device, ~~but unfortunately we failed. (Anyone out there can get them for us?)~~To further understand how the device works, attached is the United States Patent Application recently filed by Mr. Shang with USPTO.

US20080154283 - Upload a Document to Scribd

Press release: New Male Circumcision Device for HIV Prevention Studied by NewYork-Presbyterian/Weill Cornell...

United States Patent Application # 20080154283:
Apparatus for circumcising a penis

UPDATE: Hurrah! Weill Cornell Medical College has kindly provided us with the picture of ShangRing device.

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Thursday, July 10, 2008

Company Claims a Boost in IVF Rates with a New System

Ruskinn Technology of Sony Pencoed, South Wales was showing off its new Ac-tive® IVF system (Assisted Conception Total In Vitro Environment) at the European Society of Human Reproduction and Embryology annual meeting earlier this week. The company claims that their device results in higher conception rates.

From the press release, titled "New IVF "lab in a box" increases clinical pregnancy rates by 50%":

The state-of-the-art gas controlled device mimics ‘inutero’ conditions for all IVF manipulations in a single workstation. According to Ruskinn, recent clinical trials in Denmark have demonstrated an increase in clinical pregnancy rates by up to 50% in an already successful IVF laboratory using the Ac-tive workstation.
According to the Human Fertilisation and Embryology Authority, the average IVF success rate (take home baby rate) for women under 35 years of age is 29.6%1. Using the Ac-tive IVF workstation, IVF clinics could potentially increase their “take home baby rate” by 50% - from a successful 29.6% to a possible 44.4%. Ac-tive results in the production of less stressed embryos, which suggests improved implantation in the uterus and ultimately increased pregnancy rates.

Replicating the entire in-utero environment in a single, controlled-atmosphere workstation, Ac-tive delivers a stable, optimal atmosphere which simulates the environment of the human body and creates optimal conditions for embryo
culture. This means all IVF procedures – from oocyte retrieval through to embryo transfer, and including embryo culture and selection - take place in a single, stable biological atmosphere.

The Ezee Sleeve™ Bare-hand System provides ‘hands in’ access to the workstation, enabling all processes to be carried out without disturbing the carefully controlled environment.

Press release (.pdf)...

Product page: Ac-tive® IVF System...

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Friday, May 30, 2008

INVOcell Fertility Device Approved in Europe

BioXcell out of Beverly, MA has received approval in the EU to market its fertility assist device called INVOcell. The device, an incubator designed to hold a postfertilization oocyte(s), is placed into the maternal vaginal cavity. The idea is to replace the artificial in vitro fertilization (IVF) lab with a natural maternal environment to optimize early embryo development inside the INVOcell device.

From the press release:

According to Claude Ranoux, M.D., President and Chief Scientist of BioXcell, "INVOcell allows conception and embryo development to take place inside the woman's body, making having a baby simpler and less expensive, while promoting more involvement by the woman. Our device, the INVOcell, and the INVO procedure, are less expensive and simpler to perform than conventional in vitro fertilization."
Dr. Ranoux added, "The INVO procedure uses a lower stimulation approach to produce eggs for fertilization. Eggs are combined with sperm in the INVOcell device and placed in the woman's vaginal cavity where it remains for 3 days. This step eliminates the need for a complex IVF laboratory and allows the woman's body to provide the nurturing environment in which conception and early embryo development take place."

Press release: BioXcell's New INVOcell Receives CE Mark "Declaration of Conformity;" Allows Conception and Embryo Development to Take Place Inside the Woman's Body

Product page: INVOcell

Abstract: INVO: a simple, low cost effective assisted reproductive technology Human Reproduction, doi:10.1093/humrep/den163

Flashbacks: IVF Minus The Test Tube Goes On Trial

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Thursday, February 28, 2008

IVF Minus The Test Tube Goes On Trial

The Times of London is reporting that British doctors will be testing the safety and effectiveness of a new IVF procedure which lets eggs develop inside the womb rather than a test tube. According to the Times, the Care Fertility unit in Nottingham is "recruiting 40 women for the world's first clinical trial of the procedure, which intends to transform infertility treatment by exploiting the natural environment in which embryos develop." The device tested in the study is an intrauterine incubator featuring cell encapsulation technology developed by the Swiss company Anecova SA, that was profiled by us back in December. So it is nice to know that at least some of these technologies are being taken seriously by others, and not just by us.

Anecova ...

Times Online: IVF trial gives embryos a natural start in life...

Flashback to refresh our memories: Anecova IVF Technology: Where IVF Means In Vivo

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Tuesday, January 29, 2008

Control Your Sperm with A Digital Vas Deferens

If you're at your desk, please finish your drink before reading on... That's right gents, mad scientist Said Al-Sarawi will either be laughed out of the scientific community or be carried on the shoulders of frat boys as he accepts his Nobel Prize for developing the first digital sperm control device. Al-Sarawi and his team have finished their work on a synthetic valve that could be remotely opened or closed depending on your reproductive needs.

The device is placed inside the vas deferens -- the duct which carries sperm from each testicle to the penis. When closed, it blocks the flow of sperm cells, allowing them to pass again when it is opened via a remote control. The valve could be a switchable alternative to vasectomy, the researchers say.
Although women can choose from several long-term contraceptive methods, for men vasectomy is really the only option. With this procedure, the vasa deferentia are cut or blocked, a process that requires surgery and can require a week of recovery. The procedure cannot be reliably reversed, leaving some men to later regret their decision.

Now, a team from the University of Adelaide, Australia, may have come up with a more easily reversed alternative. They have designed a small radio-controlled valve that would "push-fit" snugly inside the vas deferens and block the passage of sperm.

The silicone-polymer valve can be flipped between open and closed positions with a pulse of radio waves. A set of conducting "fingers" on the valve act as antennae and convert the signal's energy into sound waves that travel through the polymer and create stresses inside the device.

"Since it is flexible, the polymer either contracts or expands as a result, and this movement allows the valve to be opened or closed as needed," explains team leader Said Al-Sarawi.

"It will be like turning a TV on and off with a remote control," added team founder Derek Abbott, "except that the remote will probably be locked away in your local doctor's office to safeguard against accidental pregnancy or potential misuse of the device."

To secure the device against accidental activation, the device works in a similar way to a car's remote key-fob. Each valve responds only to a radio-frequency signal with a unique code.

Another advantage of the microvalve is that would not require open surgery, unlike a vasectomy. The 800 micron-long device could simply be inserted using a hypodermic needle. "The procedure could be performed in a special clinic rather than in a hospital," says Abbott.

The researchers have finished the design of all parts of the valve, and are convinced it will work effectively. The next step is to test it in the lab with a tube of pressurized water. After that, trials could begin in live sheep and pigs, they say.

Just don't forget to close your vas deferens before you start partying this weekend!

New Scientist...

The image is from the Wellcome collection, presented under the Creative Commons License: Vas deferens muscles.

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Monday, December 17, 2007

Adiana Transcervical Sterilization System Occludes Tubes; Gets FDA Nod

A pre-market application of Adiana Transcervical Sterilization System from Hologic, Inc., a Bedford, Mass company, has received an approval recommendation from the FDA Obstetrics and Gynecology Devices Advisory Panel. This minimally-invasive, non-incisional new contraception device for female sterilization works by occluding Fallopian tubes by a transcervical catheter that releases a low-level of bi-polar radio frequency ablation and a special chemical "matrix" that eventually allows the clogging of the tubes.

Here are details about the device taken from the FDA Executive Summary:

The Adiana Transcervical Sterilization System consists of three principal components:
silicone matrix (one per tube);

hysteroscopic delivery catheter; and

radio-frequency (RF) generator to deliver thermal dose to tube prior to implantation.

The Adiana Transcervical Sterilization System is used to place a silicone implant, called a matrix, into each fallopian tube of the female patient to effect tubal occlusion and permanent sterilization. The delivery catheter is introduced into the patient through a hysteroscope, transvaginally and transcervically. The physician will require a separate delivery catheter to place individual matrices in each of the two fallopian tubes (two delivery catheters are needed per patient since each delivery catheter contains a single matrix). A black mark on the catheter, proximal to the electrode array and matrix, is visualized to confirm correct catheter placement prior to silicone matrix delivery. Device position is confirmed by the RF generator via the position detection array.

Once placement inside the intramural section of the fallopian tube is confirmed, the distal tip of the catheter delivers RF energy to the electrode array. Thermocouples in the catheter tip are used to maintain a constant temperature of 64°C for 60 seconds (maximum of 120 seconds of treatment per tube during a single procedure in the event that a procedure is terminated due to loss of adequate tissue contact). This creates a lesion within the fallopian tube (including destruction of the endosalpinx).

After the thermal dose is delivered, the release mechanism in the catheter is then actuated to deploy the matrix in the region of the tube where the lesion was formed. The endothelial damage provided by the RF energy encourages a tissue ingrowth response (i.e., wound-healing response). The implanted matrices provide attachment sites for tissue ingrowth, which secures the matrices in place by filling the voids in the implant. The physician conducts a hysterosalpingogram (HSG) three months after matrix placement to confirm contraceptive tubal blockage.

Press release: FDA Advisory Panel Finds Hologic's Adian® Permanent Contraception Approvable ...

FDA Exec Summary (.pdf)...

Friday, December 7, 2007

Anecova IVF Technology: Where IVF Means In Vivo

Anecova SA, a firm from Switzerland, is another recipient of the prestigious World Economic Forum's Technology Pioneer Award in Biotech/Health category. The company has developed an intrauterine device, that is essentially an incubator featuring cell encapsulation technology, that harbors and protects newly created embryos, while offering them a natural environment of the maternal uterus. The company says that preliminary study results of its device are "very encouraging."

Here's little bit more about the technology, that was co-developed with the Laboratoire d'Etude sur la Neurodégénérescence at the Ecole Polytechnique Fédérale de Lausanne (EPFL):

In the ANECOVA approach, the zygotes are placed in the maternal uterine cavity over all early development stages to get the benefits of a customized and adapted environment. The injected ovocytes are directly placed in the ANECOVA device which is then placed within the uterine cavity for the desired period. Formed embryos are then recovered and after the usual selection process, the required number is transferred as in the traditional embryo transfer procedure.
The first ANECOVA device thus restores the fertilization and early embryonic development phases back into the physiological environment of the maternal uterus instead of the laboratory incubator. This permits the development of the embryos in close communication and exchange with maternal factors from the very start of life.

A positive influence is expected on both the number and the individual quality of the embryos thus produced which should translate into better overall results of assisted reproduction.

Anecova ...

Press release: The World Economic Forum announces Technology Pioneers 2008 : The Swiss Anecova selected ...

World Economic Forum Technology Pioneers 2008 ...

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Tuesday, November 13, 2007

LIVE:ON - Save Sperm Away for a Brighter Day

In addition to the obvious fear and heartache, young men diagnosed with cancer are at a great risk of becoming infertile due to treatments like chemotherapy, radiation, or even surgery. Though many successfully fight the cancer, the thought of potential future children often gets ignored as focus is completely turned to the fight for survival. Now two foundations are working with a sperm bank to make sperm sampling and storage a breeze, straight from the oncologist's office.

The kits -- which will be distributed to oncology professionals nationwide starting this month -- contain the materials and instructions necessary for patients to produce a usable sperm sample at home or in the hospital. It includes a postage-paid package for fast delivery to Cryogenic Laboratories Inc., a Roseville, Minn., sperm bank, so no ice is needed for transport. Cryogenic Laboratories will charge $625 for processing and freezing the specimen for one year. The storage cost of each subsequent year -- frozen sperm can remain potent for decades -- is $280. In some cases, insurance will help defray that cost.
The kit, called Live:On, is also designed to eliminate a dilemma facing some men: whether to postpone treatment while pursuing sperm preservation. Gathering information about sperm preservation -- where and how to do it, how to ship off a specimen if no bank is nearby -- can take a few days. That could delay treatment of some fast-growing cancers. Armed with the kit soon to be available in oncologists' offices, however, a patient could preserve his child-bearing options in a matter of hours.

Cryogenic Laboratories will donate an unspecified percentage of its storage fees to its two partners in the effort, the Lance Armstrong Foundation and Fertile Hope, an organization dedicated to increasing fertility options for young cancer patients. Through Fertile Hope, financially strapped patients can apply for discounts.

Read on at the WSJ's Health Journal...

UPDATE: Press release from the Lance Armstrong Foundation ...

Product page: LIVE:ON ...

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Wednesday, October 31, 2007

Too "Quick on the Draw?" Durex Wants You!

Now that baseball is over, what is the average male supposed to concentrate on to prolong their "time at the office?" Have no fears fellas, the fine folks at Durex have just released a line of promotional products just for you. Unfortunately, the details are a bit sketchy, but it looks like Durex created these climax postponing pillowcases to promote their new Performa Condoms which have built-in anesthetic cream to delay the inevitable.

Enjoy!

(hat tip: Core77 Design Blog, Direct Daily)

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