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document
[ Intra-uterine insemination with controlled ovarian hyperstimulation compared to an expectant management in couples with unexplained subfertility and an intermediate prognosis : a randomised study ] . OBJECTIVE Intrauterine insemination ( IUI ) with controlled ovarian hyperstimulation ( COH ) is commonly used as treatment of first choice in couples with unexplained subfertility . This treatment should only be applied when there is a realistic increase in chance of pregnancy , particularly because it carries the increased risk of multiple pregnancies . We evaluated the effectiveness of IUI with COH relative to expectant management in couples with unexplained subfertility and an intermediate prognosis of a spontaneous ongoing pregnancy . DESIGN Multicentre randomised clinical study . METHOD 253 couples with unexplained subfertility and a probability of a spontaneous ongoing pregnancy of 30 % to 40 % within 12 months , were randomly assigned to IUI with COH for 6 months or expectant management for 6 months . The primary endpoint of our study was ongoing pregnancy within 6 months . Analysis was carried out according to the intention to treat principle . This study was registered with the Dutch Trial Register and has the International Standard Randomised Clinical Trial number ISRCTN72675518 . RESULTS Of the 253 couples included , 127 couples were allocated to IUI with COH and 126 to expectant management . In the intervention group , 42 women ( 33 % ) conceived , of which 29 pregnancies were ongoing ( 23 % ) . In the expectant management group , 40 women ( 32 % ) conceived , of which 34 pregnancies were ongoing ( 27 % ) ( relative risk : 0.85 ; 95 % CI : 0.63-1.1 ) . In the expectant management group one twin pregnancy occurred and in the intervention group one woman conceived twins and one a triplet . CONCLUSION A substantial beneficial effect of IUI with COH in couples with unexplained subfertility and an intermediate prognosis can be excluded . Expectant management for a period of 6 months therefore appears justified in these couples .
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Intervention_Surgical
controlled ovarian hyperstimulation
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Intervention_Surgical
Intrauterine insemination ( IUI )
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Intervention_Surgical
ovarian hyperstimulation ( COH )
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Intervention_Surgical
IUI with COH
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Intervention_Educational
expectant management
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Intervention_Surgical
IUI with COH
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Intervention_Surgical
IUI
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Intervention_Physical
expectant management
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Intervention_Educational
.
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Intervention_Physical
expectant management
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Intervention_Surgical
IUI with COH
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Outcome_Other
Intrauterine insemination ( IUI )
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Outcome_Other
controlled ovarian hyperstimulation ( COH )
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Outcome_Other
increase in chance of pregnancy
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Outcome_Physical
spontaneous ongoing pregnancy
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Outcome_Other
ongoing pregnancy within 6 months
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Outcome_Physical
conceived
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Outcome_Other
ongoing
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Outcome_Physical
twin pregnancy
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Outcome_Physical
twins and one a triplet
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Outcome_Physical
Expectant management
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Participant_Condition
unexplained subfertility and an intermediate prognosis
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Participant_Condition
unexplained subfertility
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Participant_Condition
unexplained subfertility
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Participant_Sample-size
253 couples
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Participant_Condition
unexplained subfertility and a probability of a spontaneous ongoing pregnancy of 30 % to 40 %