Infertility Treatment: Tests, Part 2

by Food and Drug Administration (FDA)

(Page 3 of 3)

Fulfillment Regardless

Lisa became pregnant without assisted reproductive technologies, after taking ovulation-promoting medication and undergoing surgery to repair her damaged fallopian tubes. Her daughter is now 4 years old.

"It was definitely worth it. I really appreciate having my daughter because of what I went through," she says. But Lisa and her husband won't try to have a second child just yet. "At some point you have to stop trying to have a baby, stop obsessing over what might be an unreachable goal," she says.

When having a genetically related baby seems unachievable, a couple may decide to stop treatment and proceed with the rest of their lives. Some may choose to lead an enriched life without children. Others may choose to adopt.

And no, according to Resolve, you're not more likely to get pregnant if you adopt a baby.

Science and ART

Sometimes it may be necessary or preferable to get pregnant without intercourse. A woman may choose to get pregnant with the sperm of someone who is not her partner.

In some cases, a woman may not be able to become pregnant with her partner because his sexual problems make it impossible for him to ejaculate normally during sex, or because the sperm have to bypass the vagina if the vaginal mucus cannot support them, or for other reasons. In these cases, through artificial insemination, the semen is placed into the woman's uterus or vaginal canal using a hollow, flexible tube called a catheter.

New, more complex assisted reproductive technologies, or ART, procedures, including in vitro fertilization (IVF), have been available since the birth 18 years ago of Louise Brown, the world's first "test tube baby." IVF makes it possible to combine sperm and eggs in a laboratory for a baby that is genetically related to one or both partners.

IVF (illustrated in the diagram at right) is often used when a woman's fallopian tubes are blocked. First, medication is given to stimulate the ovaries to produce multiple eggs. Once mature, the eggs are suctioned from the ovaries (1) and placed in a laboratory culture dish with the man's sperm for fertilization (2). The dish is then placed in an incubator (3). About two days later, three to five embryos are transferred to the woman's uterus (4). If the woman does not become pregnant, she may try again in the next cycle.

Other ART procedures, based on many of the same principles, include:

Gamete intrafallopian transfer, or GIFT: Similar to IVF, but used when the woman has at least one normal fallopian tube. Three to five eggs are placed in the fallopian tube, along with the man's sperm, for fertilization inside the woman's body.

Zygote intrafallopian transfer, or ZIFT (also called tubal embryo transfer): A hybrid of IVF and GIFT. The eggs retrieved from the woman's ovaries are fertilized in the lab and replaced in the fallopian tubes rather than the uterus.

Donor egg IVF: For women who, for example, have impaired ovaries or carry a genetic disease that can be transferred to the offspring. Eggs are donated by another healthy woman and fertilized in the lab with the male partner's sperm before being transferred to the female partner's uterus.

Frozen embryos: Excess embryos are frozen, to be thawed in the future if the woman doesn't get pregnant on the first cycle or wants another baby in the future.

New treatments for male factors are fast-evolving. Intracytoplasmic sperm injection is one of the most exciting new procedures, according to Benjamin Younger, M.D., executive director of the American Society for Reproductive Medicine. A single egg is injected with a single sperm to produce an embryo that can implant and grow in the uterus.

About two-thirds of births from ART procedures are single births. Of the rest, almost all are twins, with about 6 percent resulting in the birth of triplets or more.

Drug Supply Restored

The availability of sufficient supplies of the FDA-approved fertility drugs Pergonal, Metrodin, and Humegon, and the recent FDA approval of the fertility drug Fertinex have ended a sh0rtage of these types of drugs in the United States. Since the drugs are not in short supply anymore, FDA will no longer allow the importation of unapproved versions of fertility drugs, even for personal use.

In February 1995, FDA became aware of a shortage of the approved fertility drugs Pergonal and Metrodin, both manufactured by Serono Laboratories Inc of Switzerland.

Because of the shortage, FDA has allowed people to temporarily import unapproved foreign versions of fertility drugs for their own use. "FDA used its enforcement discretion to allow the importation of unapproved versions of fertility drugs on a personal use basis," says Thomas Gardine, director of the agency's division of import operations and policy.

FDA asked doctors to wait until the supply of approved drugs increased unless a patient was in the midst of therapy. "There's always a danger in taking unapproved drugs because they are of unknown quality and haven't been shown to FDA to be safe, effective, and adequately labeled," Gardine says.

The Serono manufacturing plant in Switzerland is again supplying adequate amounts of Pergonal and Metrodin for U.S. patients. Also, other products are now available for the same use.

"The drug shortage no longer exists to merit our allowing importation of the unapproved products," Gardine says. After a reasonalbe time to make the public aware of the change in FDA's position, the agency will no longer allow the unapproved versions of these drugs to enter the country.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.