Growing Concern Over Safety of High-Dose IVF Therapy

July 18, 2012 — Delivering high doses of hormones and drug is standard procedure in most fertility clinics in the U.S., but now, some experts are beginning to question the wisdom of this practice. Women who get high-dose In-Vitro Fertilization (IVF) are more likely to conceive than women who get low-dose IVF, but they are also more likely to have severe, sometimes life-threatening side effects. One study found that 10% of women who get high-dose IVF develop Ovarian Hyper-Stimulation Syndrome (OHSS), where the ovaries swell and leak significant amounts of fluid, which can increase pressure in the chest or abdominal cavity. OHSS can be life-threatening and may require hospitalization or surgery.

IVF treatment starts with an injection of Lupron, which triggers temporary menopause and suppresses the ovaries. Lupron is followed by high doses of hormones, which stimulate the ovaries and triggers the production of eggs — usually 20-30 eggs, compared with one or two during a normal cycle.

Many women are surprised to learn that Lupron has never been approved by the FDA for use in fertility treatments. It was actually developed as a treatment for prostate cancer, and the use in IVF is considered off-label. The FDA has never ordered well-controlled clinical studies of the safety of Lupron in IVF. However, adverse reactions from the drug may include liver damage, bone loss, memory loss, and chronic pain in the muscles, bones, and joints.

Not all women require high-dose IVF treatment to conceive, and some clinics are shifting to low-dose treatments. The low-dose treatments are safer and cheaper, but have a lower rate of conception than high-dose treatments. The problem is that if the low-dose treatment fails, it could be more expensive for a woman to undergo multiple cycles of treatment — including more medication, egg retrievals, anesthesia, etc. A typical high-dose treatment costs between $15,000 to $30,000 in the U.S., which is significantly higher than for most other developed nations.

Many fertility clinics in Japan and Europe have already switched to favor low-dose fertility treatments, at least to start, but clinics in the U.S. have resisted the change. One possible reason is that clinics advertise themselves based upon their percentage success-rate. They have a strong incentive to make sure every fertility treatment ends with conception.

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