title: Comparative efficacy and safety of cetrorelix with or without mid-cycle recombinant LH and leuprolide acetate for inhibition of premature LH surges in assisted reproduction.
abstract: An open label, randomized, multi-centre study was performed to compare cetrorelix and leuprolide acetate for prevention of premature LH surge and to assess whether patients treated with cetrorelix benefit from addition of recombinant human (r-h)LH. Normo-ovulatory women (n = 74) undergoing ovarian stimulation prior to intracytoplasmic sperm injection were treated with leuprolide acetate (n = 25) before ovarian stimulation with recombinant human FSH (r-hFSH) or with cetrorelix 3 mg on stimulation day 7 (with (n = 25) or without (n = 24) r-hLH 150 IU on days 7-10). The main outcome measures were the number of metaphase II (MII) oocytes retrieved; secondary efficacy end-points; adverse events (AE) and other safety measures. There were no significant differences between groups for MII oocytes retrieved, duration of stimulation, total r-hFSH dose and pregnancy rates. The group treated with cetrorelix alone had a significantly lower concentration of oestradiol per follicle compared with the other groups. The majority of AE were mild to moderate in severity. Cetrorelix and leuprolide acetate appear to have comparable efficacy and safety, although cetrorelix has the advantage of typically requiring only one injection.
authors.affiliation: Division of Reproductive Endocrinology, College of Physicians and Surgeons, Columbia University, NY, USA. mvs9@columbia.edu
authors.forename: Mark V
authors.initials: MV
authors.lastname: Sauer
authors.forename: Melvin H
authors.initials: MH
authors.lastname: Thornton
authors.forename: William
authors.initials: W
authors.lastname: Schoolcraft
authors.forename: Gary N
authors.initials: GN
authors.lastname: Frishman
mesh_terms: D000293:Adolescent; D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage* / Q000009:adverse effects; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D006727:Hormone Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy*; D016729:Leuprolide / Q000008:administration & dosage* / Q000009:adverse effects; D007986:Luteinizing Hormone / Q000008:administration & dosage* / Q000009:adverse effects; D010062:Ovulation Induction / Q000379:methods; D011247:Pregnancy; D018873:Pregnancy Rate; D027724:Reproductive Techniques, Assisted
chemical_list: D005300:Fertility Agents, Female; D006727:Hormone Antagonists; D007987:Gonadotropin-Releasing Hormone; D007986:Luteinizing Hormone; D016729:Leuprolide; C062876:cetrorelix