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

Research output: Contribution to journalArticle

104 Citations (Scopus)

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 languageEnglish
Article numbera716
Number of pages6
JournalBMJ (Clinical research ed.)
Volume337
DOIs
Publication statusPublished - 7 Aug 2008

Fingerprint

Clomiphene
Insemination
Citric Acid
Infertility
Randomized Controlled Trials
Live Birth
Birth Rate
Multiple Pregnancy
Fallopian Tubes
District Hospitals
Sperm Motility
Scotland
Spontaneous Abortion
Ovulation
Teaching Hospitals
General Hospitals
Spermatozoa
Body Mass Index
Therapeutics
Odds Ratio

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

Cite this

Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility : pragmatic randomised controlled trial. / Bhattacharya, S; Harrild, K; Mollison, Jill Ann; 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.

In: BMJ (Clinical research ed.), Vol. 337, a716, 07.08.2008.

Research output: Contribution to journalArticle

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
Bhattacharya, S ; Harrild, K ; Mollison, Jill Ann ; 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. / Clomifene citrate or unstimulated intrauterine insemination compared with expectant management for unexplained infertility : pragmatic randomised controlled trial. In: BMJ (Clinical research ed.). 2008 ; Vol. 337.
@article{70184840910244399cf400a1ae246275,
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 = "8",
day = "7",
doi = "10.1136/bmj.a716",
language = "English",
volume = "337",
journal = "BMJ",
issn = "0959-8146",
publisher = "BMJ Publishing Group",

}

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

VL - 337

JO - BMJ

JF - BMJ

SN - 0959-8146

M1 - a716

ER -