Comparing Ovarian Stimulation for Assisted Reproduction With Two Different Forms of Pituitary Suppression
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the non-inferiority of a multidose GnRH antagonist
(cetrorelix) regimen to a GnRH agonist (triptorelin) long protocol in young infertile women
undergoing ovarian stimulation with Pergoveris 150 I.U./75 I.U. (r-hFSH/ r-hLH) for ICSI
treatment because of male infertility.
To assess the efficacy of ovarian stimulation using either a GnRH antagonist (cetrorelix) or
a GnRH agonist (triptorelin) long protocol in infertile women with good prognosis and to
determine the safety of ovarian stimulation.
Subsample analysis: in 10 patients of each of both arms, serum samples will be collected
daily during the stimulation period and be stored frozen at -70 °C. The following hormone
concentrations will be measured later in single assay batches: LH, FSH, oestradiol,
progesterone, androstenedione, testosterone, inhibin A, inhibin B, AMH.
Multinational, multicentre, open label, randomized, 2-arm parallel-group phase IV study.
Eligible patients will be randomly allocated to one of the two groups: the agonist group will
receive Decapeptyl® 0.1 mg (triptorelin) starting in the mid-luteal phase of the natural
cycle until downregulation until the day of ovulation induction. The antagonist group will
receive cetrorelix 0.25 mg from stimulation day 6 to ovulation induction. In both groups,
Pergoveris® 150 I.U./75 I.U. (r-hFSH/r-hLH) will be used for ovarian stimulation from cycle
day 2 to ovulation induction.
Phase:
N/A
Details
Lead Sponsor:
University Hospital, Basel, Switzerland University of Basel