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Anastrozole single-dose protocol in women with oligo- or anovulatory infertility : results of a randomized phase II dose-response study . OBJECTIVE To compare the effects of anastrozole and clomiphene citrate ( CC ) on follicular development and ovulation in infertile women with ovulatory dysfunction . DESIGN Phase II , prospective , randomized , assessor-blind , multicenter , dose-finding , noninferiority study . SETTING Outpatient . PATIENT ( S ) Infertile women with ovulatory dysfunction , aged 18-35 years , and body mass index < 35 kg/m ( 2 ) . INTERVENTION ( S ) Single-dose anastrozole at 5 mg ( n = 39 ) , 10 mg ( n = 39 ) , 20 mg ( n = 39 ) , or 30 mg ( n = 38 ) or a 5-day course of CC at 50 mg/d ( n = 39 ) as starting doses . MAIN OUTCOME MEASURE ( S ) The primary endpoint was the ovulation rate in the first treatment cycle ( cycle 1 ) . Ovulation was defined as a midluteal phase serum P level ≥ 10 ng/mL or clinical pregnancy . RESULT ( S ) In cycle 1 the ovulation rates for a single dose of anastrozole at 5 , 10 , 20 , and 30 mg were 46.2 % , 41.0 % , 23.1 % , and 28.9 % , respectively , whereas that for CC at 50 mg/d was 61.5 % . Among women with fewer than six menses per year , the cumulative ovulation rates over three cycles were comparable in the anastrozole 5 mg ( 52.4 % ) and CC 50 mg/d ( 42.3 % ) groups . CONCLUSION ( S ) In terms of ovulation rates in cycle 1 , single-dose anastrozole at 5 , 10 , 20 , and 30 mg was not as effective as CC at 50 mg/d for 5 days ( noninferiority was not shown ) .
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Intervention_Pharmacological
Anastrozole
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Intervention_Pharmacological
anastrozole
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Intervention_Pharmacological
clomiphene citrate ( CC )
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Intervention_Pharmacological
Single-dose anastrozole
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Intervention_Pharmacological
5-day course of CC
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Outcome_Physical
follicular development and ovulation
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Outcome_Physical
ovulation rate
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Participant_Sex
women
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Participant_Condition
anovulatory infertility
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Participant_Condition
ovulatory dysfunction
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Participant_Age
18-35 years