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

BMJ, 2008-08, Vol.337 (7666), p.387-390 [Peer Reviewed Journal]

Bhattacharya et al 2008 ;Copyright 2008 BMJ Publishing Group Ltd. ;2008 INIST-CNRS ;Copyright BMJ Publishing Group LTD Aug 7, 2008 ;Bhattacharya et al 2008 2008 Bhattacharya et al ;ISSN: 0959-8138 ;ISSN: 0959-8146 ;EISSN: 1468-5833 ;EISSN: 1756-1833 ;DOI: 10.1136/bmj.a716 ;PMID: 18687718 ;CODEN: BMJOAE

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Title:
Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial
Author: Bhattacharya, S ; Harrild, K ; Mollison, J ; Wordsworth, S ; Tay, C ; Harrold, A ; McQueen, D ; Lyall, H ; Johnston, L ; Burrage, J ; Grossett, S ; Walton, H ; Lynch, J ; Johnstone, A ; Kini, S ; Raja, A ; Templeton, A
Subjects: Administration, Oral ; Adult ; Anxiety disorders ; Artificial insemination ; Biological and medical sciences ; Birth control ; Citrates ; Clinical trials ; Clomiphene - administration & dosage ; Clomiphene - adverse effects ; Clomiphene - economics ; Confidence interval ; Costs and Cost Analysis ; Depressive disorders ; Drug therapy ; Endometriosis ; Female ; Fertility Agents, Female - administration & dosage ; Fertility Agents, Female - adverse effects ; Fertility Agents, Female - economics ; General aspects ; Gynecology. Andrology. Obstetrics ; Health outcomes ; Humans ; Infertility ; Infertility, Female - drug therapy ; Infertility, Female - economics ; Insemination, Artificial, Homologous - methods ; Male ; Maternal age ; Medical sciences ; Medical treatment ; Pregnancy ; Pregnancy Outcome ; Sterility. Assisted procreation ; Time Factors ; Vivipary
Is Part Of: BMJ, 2008-08, Vol.337 (7666), p.387-390
Description: 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
Publisher: London: British Medical Journal Publishing Group
Language: English
Identifier: ISSN: 0959-8138
ISSN: 0959-8146
EISSN: 1468-5833
EISSN: 1756-1833
DOI: 10.1136/bmj.a716
PMID: 18687718
CODEN: BMJOAE
Source: BMJ Open Access Journals
MEDLINE
Alma/SFX Local Collection
ProQuest Central

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

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