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

doi:10.1136/bmj.a716

Published 7 August 2008, doi:10.1136/bmj.a716
Cite this as: BMJ 2008;337:a716

Research

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

S Bhattacharya, professor of reproductive medicine¹, K Harrild, medical statistician¹, J Mollison, senior medical statistician², S Wordsworth, senior research officer³, C Tay, consultant gynaecologist⁴, A Harrold, consultant gynaecologist⁵, D McQueen, consultant gynaecologist⁶, H Lyall, consultant gynaecologist⁷, L Johnston, research nurse¹, J Burrage, research nurse⁶, S Grossett, research nurse⁵, H Walton, research nurse⁷, J Lynch, research nurse⁷, A Johnstone, research nurse⁴, S Kini, clinical research fellow⁴, A Raja, clinical research fellow⁴, A Templeton, professor of obstetrics and gynaecology¹

¹ Department of Obstetrics and Gynaecology, University of Aberdeen, Aberdeen AB25 2ZD, ² Centre for Statistics in Medicine, University of Oxford, Wolfson College Annexe, Oxford, ³ Health Economics Research Centre, University of Oxford, Oxford, ⁴ Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, ⁵ Assisted Conception Unit, Ninewells Hospital, Dundee, ⁶ Falkirk and District Royal Infirmary, Falkirk, ⁷ ACS Unit, Ground Floor, Walton Building, Royal Infirmary, Glasgow

Correspondence to: S Bhattacharya s.bhattacharya{at}abdn.ac.uk

Objective To compare the effectiveness of clomifene citrateand unstimulated intrauterine insemination with expectant managementfor the treatment of unexplained infertility.

Design Three arm parallel group, pragmatic randomised controlledtrial.

Setting Four teaching hospitals and a district general hospitalin Scotland.

Participants Couples with infertility for over two years, confirmedovulation, patent fallopian tubes, and motile sperm.

Intervention Expectant management, oral clomifene citrate, andunstimulated intrauterine insemination.

Main outcome measures The primary outcome was live birth. Secondaryoutcome 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 intrauterineinsemination (n=193) for six months. The three randomised groupswere comparable in terms of age, body mass index, duration ofinfertility, sperm concentration, and motility. Live birth rateswere 32/193 (17%), 26/192 (14%), and 43/191 (23%), respectively.Compared with expectant management, the odds ratio for a livebirth was 0.79 (95% confidence interval 0.45 to 1.38) afterclomifene citrate and 1.46 (0.88 to 2.43) after unstimulatedintrauterine insemination. More women randomised to clomifenecitrate (159/170, 94%) and unstimulated intrauterine insemination(155/162, 96%) found the process of treatment acceptable thanthose randomised to expectant management (123/153, 80%) (P=0.001and P<0.001, respectively).

Conclusion In couples with unexplained infertility existingtreatments such as empirical clomifene and unstimulated intrauterineinsemination are unlikely to offer superior live birth ratescompared with expectant management.

Trial registration ISRCT No: 71762042

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