Aug. 10, 2008 Long established medical interventions to help couples with infertility problems do not seem to improve fertility, according to a study published on bmj.com today.
These findings challenge current practice in the UK and national guidelines should be reviewed in the light of this evidence, say the authors.
One in seven couples in the UK experience infertility. Unexplained infertility affects a quarter of these couples and common interventions to help them have been used for many years in line with fertility guidelines issued by the National Institute for Health and Clinical Excellence (NICE).
A team of researchers led by the University of Aberdeen compared the effectiveness of two specific interventions with expectant management (no treatment).
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 randomised into three groups - one group of women were encouraged to try naturally for a pregnancy and had no medical interventions; one took oral clomifene citrate (CC) which is believed to correct subtle ovulatory dysfunction; and the other had unstimulated intra-uterine insemination (IUI) of sperm.
Overall, 101 women became pregnant and had a live birth during the course of the study.
The researchers found that women who had 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 IUI had a birth rate of 23%.
They point out that to have a meaningful and significant improvement in the live birth rate, the difference in live births between unstimulated IUI and no intervention would have to be much higher than the 6% reported in this trial.
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.
Interestingly, women on active treatments (CC and IUI) were reassured by the process of treatment while women who had no interventions were less satisfied, despite it being equally effective.
The researchers conclude: "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."
In an accompanying editorial, Tarek El-Toukhy and Yacoub Khalaf from the Assisted Conception Unit at Guy's and St Thomas' NHS Foundation Trust, say: "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."
They call for high quality clinical trials to guide policymakers and to inform patients about the best treatments, and the cost effectiveness and the adverse effects associated with these interventions.
In addition, they suggest that current NICE guidelines, which endorse the use of up to six cycles of IUI without ovarian stimulation in couples with unexplained infertility, be reviewed in the light of current evidence.
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- Bhattacharya et al. Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial. BMJ, 2008; 337 (aug07 2): a716 DOI: 10.1136/bmj.a716
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