57052
document
Efficacy of different gonadotropin combinations to support ovulation induction in WHO type I anovulation infertility : clinical evidences of human recombinant FSH/human recombinant LH in a 2:1 ratio and highly purified human menopausal gonadotropin stimulation protocols . BACKGROUND The World Helath Organization ( WHO ) Group I anovulation , or hypogonadotropic hypogonadism ( HH ) , is characterized by reduced hypothalamic/pituitary activity which results in abnormally low serum FSH and LH levels and negligible estrogen activity . AIM To compare the efficacy of human recombinant FSH ( r-hFSH ) plus human recombinant LH ( r-hLH ) in a 2:1 ratio with highly purified human menopausal gonadotropin ( hMG-HP ) urinary extract , containing LH-like activity , in women with HH . SUBJECTS AND METHODS This two-arm randomized open-label study included 35 HH women ( aged 25-36 yr ) attending our Center . Eighteen patients received 150 IU hMG-HP ( 150 IU FSH + 150 IU LH-like activity ) and seventeen received 150IU r-hFSH/75IU rhLH daily for a maximum of 16 days . Ovulation was induced by a single administration of hCG on the day after the last hMG-HP or r-hFSH/r-hLH . RESULTS The primary efficacy endpoint was ovulation induction as measured by follicle ≥17 mm , pre-ovulatory estradiol ( E 2 ) ≥400 pmol/l and mid-luteal phase progesterone ( P 4 ) ≥25 nmol/l . Secondary efficacy endpoints included E 2 levels/follicle at mid-cycle , number of follicles at mid-cycle and pregnancy rate ( PR ) . Following a total of 70 cycles , 70 % of r-hFSH/r-hLH treated patients met the primary endpoint vs 88 % in hMG-HP group ( p=0.11 ) . However , PR in r-hFSH/r-hLH group was 55.6 % compared to 23.3 % in hMG-HP group ( p=0.01 ) . CONCLUSIONS The primary endpoint achievement did not correlate with PR . This study has shown the superiority of LH compared to hCG in supporting FSH-induced follicular development in HH women .
57053
Intervention_Pharmacological
gonadotropin combinations
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Intervention_Pharmacological
human recombinant FSH/human recombinant LH
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Intervention_Pharmacological
highly purified human menopausal gonadotropin
57056
Intervention_Pharmacological
human recombinant FSH ( r-hFSH ) plus human recombinant LH ( r-hLH )
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Intervention_Pharmacological
highly purified human menopausal gonadotropin ( hMG-HP ) urinary extract
57058
Intervention_Pharmacological
150 IU hMG-HP ( 150
57059
Intervention_Pharmacological
150IU r-hFSH/75IU rhLH
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Intervention_Pharmacological
hMG-HP
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Intervention_Pharmacological
r-hFSH/r-hLH
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Outcome_Physical
ovulation induction
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Outcome_Physical
ovulation induction
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Outcome_Physical
follicle
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Participant_Condition
WHO type I anovulation infertility
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Participant_Sex
women
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Participant_Sample-size
35
57068
Participant_Sex
women
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Participant_Sample-size
Eighteen
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Participant_Sample-size
seventeen