Sham: Two Common Infertility Treatments Show Little Effect

It looks as if two of the long established medical interventions that doctors use to help couples with infertility problems do not improve fertility, according to a study published in the British Medical Journal (bmj.com).

One in seven couples in Great Britain experience infertility; the numbers are nearly the same in most developed countries. Unexplained infertility affects a quarter of these couples and common interventions to help them have been used for many years. One of those is the drug clomifene citrate, and the other is actual intra-uterine insemination of what is called "unstimulated" sperm.

As it turns out, in this research a team of researchers led by the University of Aberdeen compared the effectiveness of these two specific interventions with women who had no treatment at all.

They recruited 580 women who had experienced unexplained infertility for more than two years from four teaching hospitals and a district general hospital in Scotland. The women were randomized into three groups—one group of women were encouraged to try naturally for a pregnancy without any medical interventions at all; one group took oral clomifene citrate (CC) which is believed to correct subtle ovulatory dysfunction; and the last group had unstimulated intra-uterine insemination (IUI) of sperm.

Overall, 101 women became pregnant and had a live birth during the course of the study. That's good, as pregnancies were the goal of the program. Unfortunately, the numbers did not bear out any statistical improvements for those who had the medical interventions.

The women with no interventions had a live birth rate of 17%, the group taking oral CC had a birth rate of 14%, and the group having unstimulated sperm injections had a birth rate of 23%. While that sounds like a modest improvement, it would have to be a greater improvement than 6% to be statistically meaningful. [ADDED LATER: As pointed out by reader James in a discussion of this material, when you can't conceive, even a low level shot at improving your odds may be worth trying].

Side effects for women including abdominal pain, bloating, hot flushes, nausea and headaches were highest in women taking oral CC, affecting 10–20% of women. Combined with the lower results in pregnancies, these side effects certainly appears to make that drug a poor choice. This product is marketed under various names, including Clomid, Serophene, and Milophene.

The researchers conclude: “These interventions, which have been in use for many years, are unlikely to be more effective than no treatment.”

Dave