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July 18, 2007 – The percentage of infertile men in the U.S. does not appear to have changed much over the last decade, but there has been a fivefold increase in the use of a specialized procedure during IVF for male-factor infertility, new research shows.
The study of national trends in infertility treatment showed a dramatic jump in the use of intracytoplasmic sperm injection, or ICSI, in couples undergoing in vitro fertilization (IVF).
In 1995, just 11% of IVF cycles included ICSI, but the percentage had risen to 57.5% a decade later.
The report appears in the July 19 issue of the New England Journal of Medicine.
The findings suggest ICSI is increasingly being used in conjunction with IVF for conditions other than male-factor infertility, says researcher Tarun Jain, MD, who is an assistant professor of reproductive endocrinology and infertility at the University of Illinois, Chicago.
Jain tells WebMD that it is not clear if the benefits derived from ICSI justify the added cost and potential risks for couples without a diagnosis of male infertility.
“Those studies haven’t been done,” he says. “More research is needed to determine if routine use of ICS for nonmale factor conditions is beneficial.”
Next year marks the 30th anniversary of the conception of the first human outside the body through IVF, a procedure in which egg is introduced to sperm in a Petri dish.
The first effective treatment for male infertility, characterized by poor quality or quantity of sperm, became available in 1992.
Rather than relying on the sperm to penetrate the egg on its own, ICSI involves direct injection of a single sperm into the egg.
ICSI adds about $1,500 to a single cycle of IVF, which averages about $12,400, according to figures from the American Society for Reproductive Medicine.
In their effort to assess trends in the use of IVF, with and without ICSI, Jain and colleague Ruchi Gupta, MD, MPH, of Northwestern University, analyzed national reporting data on assisted reproduction between 1995 and 2004.
The analysis included all reported IVF cycles involving fresh embryos from nondonor eggs in women during the 10-year period. From 1995 to 1998, the data included all ages, but from 1999 to 2004 data were limited to women younger than 43.
While use of IVF roughly doubled over the decade -- from 45,900 fresh-embryo cycles in 1995 to 89,500 in 2004 -- more than five times as many ICSI procedures were being done in the last year of the observation period than in the first.
The researchers found increasing use of ICSI relative to the percentage of couples with a diagnosis of male infertility in both states with and without mandated insurance coverage for infertility.
They also found an increase in the overall number of infertility clinics and the number of pregnancies and live births achieved in patients undergoing assisted reproduction.
Jain says some clinics now use ICSI routinely in couples who have failed prior IVF attempts or in those with few or poor-quality eggs, even when semen measurements are normal. He adds that a few clinics even advocate the routine use of ICSI for all IVF attempts.
Society for Assisted Reproductive Technology President David Grainger, MD, says there is little evidence that the practice improves success rates for couples without a diagnosis of male infertility.
“I can find very little medical justification for performing ICSI 100% of the time,” he says.
He says the report raises legitimate questions about the increasing use of ICSI, but he adds that limitations in the surveillance data used in the study make it difficult to draw conclusions about the frequency of use in men with normal sperm.
“Generally patients have more than one diagnosis, and that may not be reflected in the reporting,” he says. “Diagnosis with regard to IVF is not usually inaccurate, but it is often incomplete.”
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