Infertility FAQ: Part 4

by Food and Drug Administration (FDA)

(Page 4 of 4)

Q. What other types of ART are being used?

A. IVF is the most common type of ART and there are other variations on the basic procedure, some of which remain controversial. People should learn about both the benefits and risks of any medical procedure.

Intracytoplasmic sperm injection (ICSI): A single sperm is injected into an egg. If the egg is fertilized and develops normally, it is then transferred to the uterus. This has been a significant advance in treating men with low sperm count or disorders related to sperm movement. Couples who undergo the procedure should be aware that if their infertility is caused by a genetic defect, that defect could be passed to the child.

Pre-implantation genetic diagnosis: An individual cell from a growing embryo is removed and used for genetic screening during IVF.

Blastocyst culture: A blastocyst, a developed embryo, is cultured and transferred to the uterus after five or six days, compared with the three days for typical in vitro fertilization.

Cryopreservation: Human eggs and embryos are frozen so that they can be kept viable. They are stored in liquid nitrogen at 320 degrees below zero.

Assisted hatching: An opening is created in the egg shell surrounding the embryo to help it implant in the uterus. This procedure has not been shown to be beneficial for everyone undergoing ART. Those who may benefit from assisted hatching include couples who have preserved embryos, their own or donated, by cryopreservation, couples in which the mother is of an advanced age, or couples with a history of multiple failed IVF attempts.

The FDA does not regulate individual ART procedures, but the agency has cleared devices for use in ART procedures. Examples are biopsy devices, dissection needles, sperm and embryo delivery catheters, and solutions used to process and maintain sperm, eggs, and embryos.

Q. How can a couple deal with the emotional impact of infertility?

A. Kevin Garton, 40, of Vienna, Va., and his wife Sheryl, 38, sought counseling soon after they were diagnosed with infertility in 1994. A fertility evaluation revealed that Kevin produced no sperm. Kevin and his wife ultimately chose donor insemination, a process in which donor sperm was put into Sheryl's uterus. They now have three children.

"The whole process is a series of decisions," Garton says, "and it can be excruciating trying to figure things out." They obtained a referral to a psychiatrist who specializes in infertility. "We focused on coping and talking about why this happened to us and how we felt about it," he says. "I initially took the news very hard and felt that I had let my wife down, and I found out that she saw it as more of a joint issue." They also talked through treatment options with the psychiatrist.

Garton has been an active member of RESOLVE and feels that the support system has been critical in helping him and his wife deal with infertility. "People don't mean to say insensitive things, but when a couple says something like they accidentally got pregnant, it just crushes a person with infertility," Garton says. "It's important to have a group of people to talk with who are going through the same thing you are."

After they chose donor insemination, they had to deal with a range of issues, from how to choose a donor to how to discuss it with family, friends, and the children. "What it came down to for us," Garton says, "is that whether you conceive naturally, get medical treatment, or adopt, your kids are your kids. When you are diagnosed with infertility, you think you're different in some way at first. But I'm just a regular person who wanted to make a family."

FDA Regulation of Human Tissue

The FDA has recently published proposed and final rules to strengthen regulation of human tissue, and expanded the regulations to include human cells, tissues, and cellular and tissue-based products. The new regulations apply to reproductive tissues such as eggs, embryos, and semen.

The rule on registration and listing of the products was finalized on Jan. 19, 2001, and the FDA began requiring various establishments to register with the agency and list the products manufactured starting on March 29, 2004. These establishments include those that recover, process, store, label, package, or distribute the products, or that screen or test donors of them. More than 350 reproductive establishments, including semen banks and fertility clinics, have registered with the FDA.

Reproductive establishments also will be required to comply with donor eligibility requirements, which become effective on May 25, 2005. These requirements establish screening and testing criteria for donors of human cells, tissues, and cellular and tissue-based products to help prevent the transmission of communicable diseases. People who are donating to their own sexual partners are not required to be screened or tested. The regulations do require screening and testing for reproductive product donors who are not sexually intimate partners of people receiving the donation.

FDA experts say that the agency is sensitive to the desire to begin or expand families, and that the regulations are designed to enhance the safety of reproductive tissue, while at the same time recognizing that couples or individuals who know each other should be given the opportunity to make informed decisions about the use of donated reproductive tissue.

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.