New Research Questions Use Of Common Fertility Treatments

A new study published on bmj.com has found that fertility is not improved in infertile couples who have been treated with long-established medical interventions. The team of researchers led by the University of Aberdeen has called for UK and national guidelines to be reviewed with this new evidence that challenges current practices.

In the UK, one in seven couples experience infertility. Of these, about 25% of the infertility is unexplained, and the standard treatment includes a body of common interventions that have been used for years and have been issued by the National Institute for Health and Clinical Excellence (NICE).

The research team set out to compare two specific interventions with expectant management (i.e., no treatment). From four teaching hospitals and a district general hospital in Scotland, they recruited a sample of 580 women who have had unexplained infertility for over two years. The women were randomly assigned such that one group had no medical intervention and tried naturally to become pregnant, a second group took oral clomifene citrate (CC) to correct subtle ovulatory dysfunction, and a third group received unstimulated intra-uterine insemination (IUI) of sperm.

During the course of the study, 101 women became pregnant and had a live birth. The birth rate for women with no intervention was 17%, and the rates for the oral CC group and the IUI group were 14% and 23%, respectively. According to the researchers, the 6% difference between the IUI and the non-intervention group is no large enough for the results to suggest a meaningful and significant improvement in the live birth rate.

Many women suffered from side effects that included: pain, bloating, hot flushes, nausea and headaches. These affected about 10 to 20% of women, most of whom were taking oral CC. Also, it is worth noting that satisfaction was higher in the groups of women being actively treated - as they were reassured by the treatment process - compared to women who received no intervention.

"These interventions, which have been in use for many years, are unlikely to be more effective than no treatment. These results challenge current practice, as endorsed by a national guideline in the UK," conclude the authors.

Tarek El-Toukhy and Yacoub Khalaf (Assisted Conception Unit at Guy's and St Thomas' NHS Foundation Trust) write in an accompanying editorial that: "As a direct result of the lack of evidence, many couples with unexplained infertility endure (and even request) expensive, potentially hazardous, and often unnecessary treatments." There is a need for high quality clinical trials as well as better information for patients to determine the best treatments in light of effectiveness and adverse effects. El-Toukhy and Khalaf also call for the current NICE guidelines to be reviewed with this research in mind.

Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial
S Bhattacharya, K Harrild, J Mollison, S Wordsworth, C Tay, A Harrold, D McQueen, H Lyall, L Johnston, J Burrage, S Grossett, H Walton, J Lynch, A Johnstone, S Kini, A Raja, A Templeton
BMJ (2008). 337: a716.
doi:10.1136/bmj.a716