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

S Bhattacharya; K Harrild; Jill Ann Mollison; S Wordsworth; C Tay; A Harrold; D McQueen; H Lyall; L Johnston; J Burrage; S Grossett; H Walton; J Lynch; A Johnstone; S Kini; A Raja; A Templeton

doi:10.1136/bmj.a716

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

S Bhattacharya, K Harrild, Jill Ann Mollison, S Wordsworth, C Tay, A Harrold, D McQueen, H Lyall, L Johnston, J Burrage, S Grossett, H Walton, J Lynch, A Johnstone, S Kini, A Raja, A Templeton

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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.

Original language	English
Article number	a716
Number of pages	6
Journal	BMJ (Clinical research ed.)
Volume	337
DOIs	https://doi.org/10.1136/bmj.a716
Publication status	Published - 7 Aug 2008

Keywords

Administration, Oral
Adult
Clomiphene
Costs and Cost Analysis
Female
Fertility Agents, Female
Humans
Infertility, Female
Insemination, Artificial, Homologous
Male
Pregnancy
Pregnancy Outcome
Time Factors

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10.1136/bmj.a716

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Bhattacharya, S., Harrild, K., Mollison, J. A., 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. (2008). Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial. BMJ (Clinical research ed.), 337, Article a716. https://doi.org/10.1136/bmj.a716

Bhattacharya, S, Harrild, K, Mollison, JA, 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 2008, 'Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility: pragmatic randomised controlled trial', BMJ (Clinical research ed.), vol. 337, a716. https://doi.org/10.1136/bmj.a716

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

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. ",

keywords = "Administration, Oral, Adult, Clomiphene, Costs and Cost Analysis, Female, Fertility Agents, Female, Humans, Infertility, Female, Insemination, Artificial, Homologous, Male, Pregnancy, Pregnancy Outcome, Time Factors",

author = "S Bhattacharya and K Harrild and Mollison, {Jill Ann} and S Wordsworth and C Tay and A Harrold and D McQueen and H Lyall and L Johnston and J Burrage and S Grossett and H Walton and J Lynch and A Johnstone and S Kini and A Raja and A Templeton",

year = "2008",

month = aug,

day = "7",

doi = "10.1136/bmj.a716",

language = "English",

volume = "337",

journal = "BMJ (Clinical research ed.)",

issn = "1468-5833",

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TY - JOUR

T1 - Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility

T2 - pragmatic randomised controlled trial

AU - Bhattacharya, S

AU - Harrild, K

AU - Mollison, Jill Ann

AU - Wordsworth, S

AU - Tay, C

AU - Harrold, A

AU - McQueen, D

AU - Lyall, H

AU - Johnston, L

AU - Burrage, J

AU - Grossett, S

AU - Walton, H

AU - Lynch, J

AU - Johnstone, A

AU - Kini, S

AU - Raja, A

AU - Templeton, A

PY - 2008/8/7

Y1 - 2008/8/7

N2 - 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.

AB - 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.

KW - Administration, Oral

KW - Adult

KW - Clomiphene

KW - Costs and Cost Analysis

KW - Female

KW - Fertility Agents, Female

KW - Humans

KW - Infertility, Female

KW - Insemination, Artificial, Homologous

KW - Male

KW - Pregnancy

KW - Pregnancy Outcome

KW - Time Factors

U2 - 10.1136/bmj.a716

DO - 10.1136/bmj.a716

M3 - Article

C2 - 18687718

SN - 1468-5833

VL - 337

JO - BMJ (Clinical research ed.)

JF - BMJ (Clinical research ed.)

M1 - a716

ER -

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

Abstract

Keywords

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