Infertility FAQ: Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

Q. What are the conventional treatments for infertility?

A. Conventional therapies, such as drugs or surgery, are used to treat 85 percent to 90 percent of infertility cases. Examples of reproductive surgery for men are vasectomy reversal and varicocele repair, a procedure that may restore fertility by treating varicose veins in the scrotum. Examples of fertility-related surgery for women include removal of noncancerous tumors in the uterus called fibroids, and the removal of endometriosis implants, which can cause infertility.

There are two types of ovulation drug treatments approved by the FDA. Clomid and Serophene (clomiphene citrate) are taken by mouth. Repronex and Pergonal (human gonadotropins) are injected. Both types stimulate the ovaries to produce eggs.

Clomiphene is usually the first line of treatment in women with ovulation problems. "In women who are not ovulating, 60 percent to 85 percent of women will ovulate with clomiphene, and 30 percent to 40 percent will become pregnant," says Audrey Gassman, M.D., a medical reviewer in the FDA's Division of Reproductive and Urologic Drug Products. One of the risks of ovulation-inducing drugs is that more than one fetus may result.

Drugs that stimulate ovulation are often used with intrauterine insemination, a procedure in which millions of sperm are inserted into a woman's uterus around the time of ovulation to increase the chance of pregnancy. A partner's sperm or donor sperm may be used.

Q. What are the side effects of fertility drugs?

A. Among the most common bothersome side effects of clomiphene are hot flashes, which occur in 10 percent of women. Abdominal discomfort and bloating is seen in less than 5 percent. Less common are nausea, vomiting, and breast discomfort, which occur in 2 percent of women. Gonadotropins can cause side effects similar to clomiphene. The most common serious adverse event with gonadotropins is ovarian hyperstimulation syndrome. This causes ovarian enlargement and pain and an accumulation of fluid in the abdomen that is potentially dangerous. This results in pain in the pelvic area.

The occurrence of ovarian hyperstimulation syndrome varies with the gonadotropin used, but with most gonadotropins, hyperstimulation occurs in 5 percent to 7 percent of women, with severe cases affecting less than 2 percent of patients, according to Gassman. Mild cases may result in the development of ovarian cysts. "In severe cases of this, patients may need to be hospitalized for lung, kidney, and liver problems, and deaths have been reported, but this is rare," Gassman says. People who experience bothersome side effects while taking fertility drugs should see their doctors.

The incidence of multiple pregnancies with clomiphene is about 8 percent, and the incidence of multiple pregnancies with gonadotropins is up to 20 percent. In contrast, the rate of multiple infant births is 3 percent in the general U.S. population, according to a 2001 report on ART success rates published by the Centers for Disease Control and Prevention (CDC) and the ASRM. Most of the cases of multiple pregnancies due to ovulation-stimulating drugs result in twins, according to the ASRM, but up to 5 percent result in triplets or a higher number of babies. A multiple pregnancy significantly raises the risk of preterm labor, pregnancy complications for the mother, and low birth weight and long-term disability in babies.

Q. Do fertility drugs cause ovarian cancer?

A. Concern over a link between fertility drugs and ovarian cancer came from studies published in the early 1990s that suggested the risk of ovarian cancer might be significantly increased in women exposed to ovulation drugs. "But more recent studies have failed to corroborate a strong association between fertility drugs and ovarian cancer in the general population," Gassman says.

One study, supported by the National Cancer Institute, evaluated more than 12,000 women and did not find a strong link between ovulation-stimulating drugs (clomiphene and gonadotropins) and ovarian cancer. The researchers also concluded that slight but non-significant elevations in risk with drug use among certain subgroups support the need to continue monitoring long-term risks. The study was published in the June 2004 issue of Obstetrics and Gynecology, the journal of the American College of Obstetricians and Gynecologists.

Gassman says, "The FDA continues to monitor adverse events possibly associated with these drugs and takes appropriate action when necessary based on our current understanding of the risks and benefits."

Q. What is the role of assisted reproductive technology?

A. ART is used when conventional treatment has failed or when no other treatment is available, such as when the woman's tubes cannot be repaired or the man's sperm count is very low. In vitro fertilization and embryo transfer (IVF-ET) accounts for 98 percent of ART procedures, according to the CDC.

Amy Stewart, 29, a nursing home administrator in Warrenton, Ga., turned to in vitro fertilization after exhausting other options. She was diagnosed with endometriosis in 2000 and became pregnant in 2001 after taking fertility drugs. But her pregnancy was ectopic, a dangerous condition in which the fertilized egg implants outside of the uterus, usually in the fallopian tubes. Surgery to treat the ectopic pregnancy resulted in further scarring of her fallopian tubes. She later took fertility drugs in preparation for intrauterine insemination (IUI), and had three unsuccessful IUI attempts. On the fourth IUI attempt, the procedure was canceled because the prognosis for success was poor.

To begin the IVF process, Stewart took fertility drugs to stimulate her ovaries to produce many eggs. In March 2003, her eggs were retrieved and put in a dish with her husband's sperm. About 24 hours later, they were checked to see if fertilization had taken place. It had, and the resulting embryo was transferred directly into her uterus, bypassing the fallopian tubes. Stewart found out she was pregnant on March 19, 2003, and had a baby boy in November 2003. In vitro fertilization can also be performed with donor eggs or donor sperm.

According to the CDC, in 2001, 40 percent of ART procedures that progressed to the "transfer" stage resulted in pregnancy, and 33 percent resulted in live-birth deliveries. "Transfer" refers to transfer of the embryo from an incubation vessel to the uterus. Data were collected from 385 U.S. medical centers by the Society for Assisted Reproductive Technology, an affiliate of the ASRM.

As a result of ART procedures conducted in 2001, the CDC reported that there were 29,344 live-birth deliveries and 40,687 infants total. The difference in the number of deliveries compared to infants born is due to multiple pregnancies. People who use ART are more likely to have multiple births than those who conceive naturally. This risk should be discussed with a doctor. The number of pregnancies resulting in triplets or a higher number of babies has decreased since 1999, when the ASRM updated guidelines on the number of embryos that should be transferred into the uterus.

According to the ASRM, the average cost of an IVF cycle is $12,400. Health insurance coverage for infertility depends on where consumers live and the type of services needed. As of September 2004, the following 14 states required insurers to cover some form of infertility treatment: Arkansas, California, Connecticut, Hawaii, Illinois, Maryland, Massachusetts, Montana, New Jersey, New York, Ohio, Rhode Island, Texas, and West Virginia.

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