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BMJ. 2008 Aug 7;337:a716. doi: 10.1136/bmj.a716.

Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial.

Author information

1
Department of Obstetrics and Gynaecology, University of Aberdeen, Aberdeen AB25 2ZD. s.bhattacharya@abdn.ac.uk

Abstract

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, 96%) found the process of treatment acceptable than those randomised to expectant management (123/153, 80%) (P=0.001 and P<0.001, respectively).

CONCLUSION:

In couples with unexplained infertility existing treatments such as empirical clomifene and unstimulated intrauterine insemination are unlikely to offer superior live birth rates compared with expectant management.

TRIAL REGISTRATION:

ISRCT No: 71762042.

PMID:
18687718
PMCID:
PMC2505091
[Indexed for MEDLINE]
Free PMC Article

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