INFERTILITY KIT CREATED AS IN-VITRO ALTERNATIVE : LOWER COST, LESS CHANCE OF MULTIPLE BIRTHS TOUTED BY ITS DEVELOPER, BUT MEDICAL EXPERTS AREN'T SOLD.

Byline: Joann Muller The Boston Globe

For eight years, Dr. Claude Ranoux has quietly developed a new approach to treating infertility that costs substantially less than the standard method, and is less risky for women.

Now, he's ready to begin marketing it.

The French-born Ranoux has formed Biofertec Ltd., a start-up company that will train physicians in the use of his patented technology known as intra vaginal culture (IVC).

IVC's promise lies in the fact that it can be performed by an obstetrician/gynecologist in the doctor's office for less than half the cost of the standard infertility treatment, and it doesn't require large doses of expensive fertility drugs that can often cause side effects.

If the procedure takes off as Ranoux expects, Biofertec projects that it could reap $100 million in revenues within five years. The money would come from fees charged to train doctors in how to do the procedure and from the sale of $375 kits containing the patented equipment needed to perform it.

But fertility specialists are skeptical of Ranoux's technique, saying it doesn't yield as many babies as the standard procedure, called in-vitro fertilization (IVF).

``It's (Biofertec's concept) been around for quite a few years, but the fact that a lot of other people haven't embraced it may be telling,'' said Kenneth Ryan, professor emeritus of Ob/Gyn-fertility at Harvard University, who is also chairman of the ethics committees for the American Society of Reproductive Medicine and Brigham & Women's Hospital in Boston.

That enrages Biofertec officials, who say IVC's birth rates are close to those achieved using IVF and the only reason fertility specialists are condemning the new procedure is because it'll cut substantially into their income.

``The reason (fertility specialists) are so negative about it is because IVF doctors are making an average fee of $4,200 off IVF, and we're sinking that (fee) down to $1,200. They don't want their income cut by three-quarters,'' said Jo Ann Jorge, vice president and chief operating officer of Biofertec.

``They've tried to block us from every direction. But now we have the capital and resources to market IVC at a comparable level,'' she said.

Biofertec said it received three investment offers, ranging from $2.5 million to $4.5 million, from venture capital companies, but turned them down because Ranoux was unwilling to hand over control of his patents.

Instead, the company has raised $1.2 million from private investors, including $700,000 of Ranoux's own money.

The funds will be used to begin production of a patented medical device needed to perform the procedure, and to begin a major marketing campaign promoting the benefits of IVC to doctors, insurance companies and consumers.

``We will pursue the same markets and marketing path that IVF has pursued,'' said Jorge.

The kits will be manufactured by Louisville Laboratories of Kentucky, which has invested $200,000 in Biofertec, and will be distributed through Fertility Technologies Inc. of Natick, Mass., which has guaranteed it will buy half the production.

By touting the low cost and low risk associated with IVC, Biofertec expects to enlist nearly 10 percent of the nation's 34,000 obstetrician/gynecologists to perform the procedure themselves, rather than referring their patients to fertility specialists.

Biofertec's aggressive plans highlight the increasing competition in the highly lucrative, but emotionally charged, fertility industry.

Infertility - a failure to conceive after a year of unprotected sex - affects nearly one out of five married couples in the United States.

Each year, 2.3 million couples spend $2 billion attempting to overcome reproductive problems.

Most begin by taking drugs to make them ovulate more regularly, but those who still don't get pregnant often move on to more complicated assisted reproduction technologies that cost $8,000 to $12,000 per attempt. These typically involve removing numerous eggs from a woman's ovaries, fertilizing them in a laboratory, and returning the embryos to the woman's body.

Even with the help of science, however, the chances of getting pregnant through such assisted reproduction techniques are only about one in five, leaving many couples disappointed - and $30,000 to $40,000 poorer.

Still, the industry has grown steadily since the first test tube baby, Louise Brown, was born in England 18 years ago. There are now 300 fertility clinics in the United States, 10 times as many as there were just a decade ago.

While the industry has grown, however, so has the controversy surrounding assisted reproduction.

Many women worry about the health effects of taking high doses of hormone drugs that many of the procedures require. And because the fertility industry is largely unhampered by government regulation, clinics are free to experiment on their patients. High-profile cases of abuse involving lost or destroyed embryos have also raised red flags.

Such concerns are at the core of Biofertec's marketing strategy.

``The timing couldn't be better for launching our procedure because people are looking for an alternative,'' said company President J. Tyler Dean, who added that IVC ``opens the door for people who couldn't afford fertility treatment.''

The new procedure costs about $3,500 for the entire procedure, far less than in-vitro fertilization, because there are no expensive drugs or laboratory charges.

In the standard approach, a woman receives daily injections of powerful hormones to stimulate her ovaries - which normally produce only one egg a month - to produce as many as 20 eggs.

When she is close to ovulation, she goes to a hospital where she is heavily sedated and the eggs are retrieved surgically. The eggs are then fertilized in a laboratory petri dish using her partner's sperm, and later implanted in her uterus. Some of the embryos may be frozen for later implantation.

In Biofertec's approach, ovulation is allowed to proceed naturally, or with very low-level stimulation. When tests show the woman is ready to ovulate, she goes to her doctor's office, where she takes a painkiller before the doctor uses a small needle to harvest one to three eggs through the back wall of the vagina. The egg is then fertilized with the sperm and sealed in a patented plastic vial that Ranoux developed. The woman then inserts the tube into her vagina, much like a tampon, where it incubates for two days. Then, the embryo is implanted in the uterus, just as it is in standard in-vitro fertilization.

Since usually only one egg is used, and incubation occurs inside the woman's body, not in a lab, there is less chance for multiple births or misplaced embryos, according to Biofertec.

The intimacy of carrying the tube inside her was the most appealing part to Karen, 41, who gave birth to a son two years ago after undergoing IVC in the Brookline office of Dr. Gary Gross, one of a handful of U.S. doctors performing the procedure on a regular basis. (She asked that her last name not be used to protect her family's privacy.)

``There's so much that is high-tech and medical about this whole process - I mean, you don't even have sex to have a baby. Something about the fact that he was conceived inside my body meant a tremendous amount to me emotionally, because the rest of the thing was so weird and out there.''

In fact, natural egg retrieval has been around for years, but without ultrasound and other technology to pinpoint the exact time of ovulation, there was a high failure rate, said her doctor.

Instead, doctors focused on developing ways to stimulate a woman to produce more eggs, so they could all be fertilized at once, and the best embryos implanted in the uterus. The philosophy was simple: the more fertilized eggs transferred back to the woman's body, the higher the chances of pregnancy.

But now, Gross said, Ranoux has perfected natural cycle retrieval, making IVC success rates closer to those of standard IVF.

So far, about 2,000 IVC procedures have been done worldwide, including 600 in the United States by Ranoux, Gross or a handful of other doctors. The success rate, according to Ranoux, is 7 percent to 15 percent, depending on how many eggs were used. That compares to 10 percent to 15 percent for standard IVF, Ranoux says.

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Photo: Dr. Claude Ranoux of Biofertec Ltd. holds a tube tha t is part of his company's treatment for infertility.

New York Times