The British Medical Journal has published the results of a randomised controlled trial that aimed to compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility. The study has been reported in the general media (BBC).
580 women were recruited to the study with a primary outcome measure of live birth. In addition data were collected to assess how acceptable the method of treatment was to the patient. The women were well matched in terms of age, body mass index, duration of infertility and partners' sperm concentration and motility.
- 32/193 (17%) of those women in the expectant management arm gave birth to a live child
- 26/192 (14%) of those women in the oral clomifene citrate arm gave birth to a live child
- 43/191 (23%) of those women in the unstimulated intrauterine insemination gave birth to a live child
There were no statistical differences when comparing either active treatment arm with expectant management. However, a greater proportion of women in the treatment arms (94% for clomifene citrate and 96% for intrauterine insemination) found the treatment method acceptable compared to those in the expectant management arm (80%).
The authors conclude that active treatment is "unlikely to offer superior live birth rates compared with expectant management". They also point out "women with infertility are reassured by active treatment and are less satisfied with an expectant approach".
Action: This study may start to challenge current practice in the treatment of unexplained infertility. It may be appropriate to find another way of reassuring couples who are trying to start a family rather than resorting to ineffective treatments.