Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial

Pieternel Steures, Jan Willem van der Steeg, Peter GA Hompes, J. Dik F Habbema, Marinus JC Eijkemans, Frank J. Broekmans, Harold R. Verhoeve, Patrick MM Bossuyt, Fulco van der Veen, Ben WJ Mol

Research output: Contribution to journalArticle

128 Citations (Scopus)

Abstract

Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pregnancy, a couple's chances of achieving an ongoing pregnancy without it should be considered to identify those most likely to benefit from treatment. We aimed to assess the incremental effectiveness of intrauterine insemination with controlled ovarian hyperstimulation compared with expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy. Methods: 253 couples with unexplained subfertility and a 30-40% probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either intrauterine insemination with controlled ovarian hyperstimulation for 6 months or expectant management for 6 months. The primary endpoint of this hospital-based study was ongoing pregnancy within 6 months. Analysis was by intention to treat. This trial is registered with the Dutch Trial Register and as an International Standard Randomised Clinical Trial, number ISRCTN72675518. Findings: Of the 253 couples enrolled, 127 were assigned intrauterine insemination with controlled ovarian hyperstimulation and 126 expectant management. In the intervention group, 42 (33%) women conceived and 29 (23%) pregnancies were ongoing. In the expectant management group, 40 (32%) women conceived and 34 (27%) pregnancies were ongoing (relative risk 0·85, 95% CI 0·63-1·1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets. Interpretation: A large beneficial effect of intrauterine insemination with controlled ovarian hyperstimulation in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for 6 months is therefore justified in these couples.

LanguageEnglish
Pages216-221
Number of pages6
JournalLancet
Volume368
Issue number9531
DOIs
Publication statusPublished - 15 Jul 2006
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Steures, Pieternel ; van der Steeg, Jan Willem ; Hompes, Peter GA ; Habbema, J. Dik F ; Eijkemans, Marinus JC ; Broekmans, Frank J. ; Verhoeve, Harold R. ; Bossuyt, Patrick MM ; van der Veen, Fulco ; Mol, Ben WJ. / Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis : a randomised clinical trial. In: Lancet. 2006 ; Vol. 368, No. 9531. pp. 216-221.
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title = "Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial",
abstract = "Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pregnancy, a couple's chances of achieving an ongoing pregnancy without it should be considered to identify those most likely to benefit from treatment. We aimed to assess the incremental effectiveness of intrauterine insemination with controlled ovarian hyperstimulation compared with expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy. Methods: 253 couples with unexplained subfertility and a 30-40{\%} probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either intrauterine insemination with controlled ovarian hyperstimulation for 6 months or expectant management for 6 months. The primary endpoint of this hospital-based study was ongoing pregnancy within 6 months. Analysis was by intention to treat. This trial is registered with the Dutch Trial Register and as an International Standard Randomised Clinical Trial, number ISRCTN72675518. Findings: Of the 253 couples enrolled, 127 were assigned intrauterine insemination with controlled ovarian hyperstimulation and 126 expectant management. In the intervention group, 42 (33{\%}) women conceived and 29 (23{\%}) pregnancies were ongoing. In the expectant management group, 40 (32{\%}) women conceived and 34 (27{\%}) pregnancies were ongoing (relative risk 0·85, 95{\%} CI 0·63-1·1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets. Interpretation: A large beneficial effect of intrauterine insemination with controlled ovarian hyperstimulation in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for 6 months is therefore justified in these couples.",
author = "Pieternel Steures and {van der Steeg}, {Jan Willem} and Hompes, {Peter GA} and Habbema, {J. Dik F} and Eijkemans, {Marinus JC} and Broekmans, {Frank J.} and Verhoeve, {Harold R.} and Bossuyt, {Patrick MM} and {van der Veen}, Fulco and Mol, {Ben WJ}",
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Steures, P, van der Steeg, JW, Hompes, PGA, Habbema, JDF, Eijkemans, MJC, Broekmans, FJ, Verhoeve, HR, Bossuyt, PMM, van der Veen, F & Mol, BWJ 2006, 'Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis: a randomised clinical trial', Lancet, vol. 368, no. 9531, pp. 216-221. https://doi.org/10.1016/S0140-6736(06)69042-9

Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis : a randomised clinical trial. / Steures, Pieternel; van der Steeg, Jan Willem; Hompes, Peter GA; Habbema, J. Dik F; Eijkemans, Marinus JC; Broekmans, Frank J.; Verhoeve, Harold R.; Bossuyt, Patrick MM; van der Veen, Fulco; Mol, Ben WJ.

In: Lancet, Vol. 368, No. 9531, 15.07.2006, p. 216-221.

Research output: Contribution to journalArticle

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T1 - Intrauterine insemination with controlled ovarian hyperstimulation versus expectant management for couples with unexplained subfertility and an intermediate prognosis

T2 - Lancet

AU - Steures, Pieternel

AU - van der Steeg, Jan Willem

AU - Hompes, Peter GA

AU - Habbema, J. Dik F

AU - Eijkemans, Marinus JC

AU - Broekmans, Frank J.

AU - Verhoeve, Harold R.

AU - Bossuyt, Patrick MM

AU - van der Veen, Fulco

AU - Mol, Ben WJ

PY - 2006/7/15

Y1 - 2006/7/15

N2 - Background: Intrauterine insemination with controlled ovarian hyperstimulation is commonly used as first-line treatment for couples with unexplained subfertility. Since such treatment increases the risk of multiple pregnancy, a couple's chances of achieving an ongoing pregnancy without it should be considered to identify those most likely to benefit from treatment. We aimed to assess the incremental effectiveness of intrauterine insemination with controlled ovarian hyperstimulation compared with expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy. Methods: 253 couples with unexplained subfertility and a 30-40% probability of a spontaneous ongoing pregnancy within 12 months were randomly assigned either intrauterine insemination with controlled ovarian hyperstimulation for 6 months or expectant management for 6 months. The primary endpoint of this hospital-based study was ongoing pregnancy within 6 months. Analysis was by intention to treat. This trial is registered with the Dutch Trial Register and as an International Standard Randomised Clinical Trial, number ISRCTN72675518. Findings: Of the 253 couples enrolled, 127 were assigned intrauterine insemination with controlled ovarian hyperstimulation and 126 expectant management. In the intervention group, 42 (33%) women conceived and 29 (23%) pregnancies were ongoing. In the expectant management group, 40 (32%) women conceived and 34 (27%) pregnancies were ongoing (relative risk 0·85, 95% CI 0·63-1·1). There was one twin pregnancy in each study group, and one woman in the intervention group conceived triplets. Interpretation: A large beneficial effect of intrauterine insemination with controlled ovarian hyperstimulation in couples with unexplained subfertility and an intermediate prognosis can be excluded. Expectant management for 6 months is therefore justified in these couples.

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