Objective To compare the effectiveness of clomifene citrate and unstimulated intrauterine insemination with expectant management for the treatment of unexplained infertility. Design Three arm parallel group, pragmatic randomised controlled trial. Setting Four teaching hospitals and a district general hospital in Scotland. Participants Couples with infertility for over two years, confirmed ovulation, patent fallopian tubes, and motile sperm. Intervention Expectant management, oral clomifene citrate, and unstimulated intrauterine insemination. Main outcome measures The primary outcome was live birth. Secondary outcome measures included clinical pregnancy, multiple pregnancy, miscarriage, and acceptability. Results 580 women were randomised to expectant management (n=193), oral clomifene citrate (n=194), or unstimulated intrauterine insemination (n=193) for six months. The three randomised groups were comparable in terms of age, body mass index, duration of infertility, sperm concentration, and motility. Live birth rates were 32/193 (17%), 26/192 (14%), and 43/191 (23%), respectively. Compared with expectant management, the odds ratio for a live birth was 0.79 (95% confidence interval 0.45 to 1.38) after clomifene citrate and 1.46 (0.88 to 2.43) after unstimulated intrauterine insemination. More women randomised to clomifene citrate (159/170, 94%) and unstimulated intrauterine insemination (155/162,
Despite being more expensive, existing treatments such as empirical CC and unstimulated IUI do not offer superior live birth rates compared with EM of unexplained infertility. They are unlikely to be a cost-effective use of limited NHS resources. The study's main limitation is that it did not consider the psychological effects on couples. ISRCT Number: 71762042.
Purpose To evaluate the role of Anti-mullerian hormone (AMH) in predicting cumulative pregnancy outcome during in-vitro fertilization (IVF) treatment. Methods Serum AMH levels on day 6 of ovarian stimulation were taken from 180 women undergoing IVF with or without intracytoplasmic sperm injection (ICSI). The main outcome measures were ongoing pregnancy in the fresh cycle, cumulative ongoing pregnancy and ovarian response.Results There was a trend of higher median AMH levels in subjects achieving ongoing pregnancy in the fresh IVF cycle. The median AMH levels were significantly higher in subjects attaining ongoing pregnancy cumulatively and in subjects showing ovarian hyper-response in the stimulated cycle. Areas under the ROC curves were 0.606 and 0.792 for the prediction of cumulative ongoing pregnancy and ovarian hyper-response respectively. Conclusions Serum AMH concentration on day 6 of stimulation was significantly higher in subjects who achieved cumulative ongoing pregnancy in IVF compared to those who did not. Serum AMH is a reasonably good predictor of ovarian hyper-response.
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