Objective: To explore the comparative efficacy, safety, and tolerability of agents used for ovarian stimulation and luteal support when applied in a population of women undergoing in vitro fertilization (IVF) using a gonadotropin-releasing hormone (GnRH) antagonist protocol.
Study Design: A phase 4, multicenter, randomized, open-label, exploratory clinical trial was performed at 7 assisted reproductive technology centers in the United States. Subjects included 173 women aged 18-42 years with a documented history of infertility who were undergoing IVF.
Background: The safety and tolerability of a new highly purified, urine-derived human menopausal gonadotropin (hMG) preparation [Menopur] was compared with a currently available hMG [Repronex] in women undergoing in vitro fertilization (IVF).
Methods: This was a randomized, open-label, parallel-group, multicenter study conducted in subjects undergoing IVF. Women (N = 125), 18-39 years of age, underwent pituitary down-regulation with leuprolide acetate beginning 7 days prior to onset of menses and continuing up to the day before hCG administration.
Objective: To determine whether Oxiplex/AP Gel (FzioMed, San Luis Obispo, CA) was safe and preliminarily effective in reducing postsurgical adhesions after adnexal surgery by laparoscopy.
Design: Prospective, multicenter, double-blind, randomized, U.S.
Reprod Biol Endocrinol
October 2003
Background: These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta (Follistim) in women undergoing in vitro fertilization.
Methods: This report describes the pooled data from two, nearly identical, randomized, controlled, parallel-group, multicenter studies conducted in a total of 19 academic and private IVF-ET centers in the United States. Infertile premenopausal women underwent pituitary down-regulation using leuprolide acetate followed by a maximum of 12 days of subcutaneous Bravelle (n = 120) or Follistim (n = 118), followed by administration of human chorionic gonadotropin, oocyte retrieval and embryo transfer.
Objective: To evaluate controlled ovarian stimulation cycles using the GnRH antagonist ganirelix in combination with the recombinant FSH, follitropin-beta, in women with polycystic ovary syndrome (PCOS).
Design: Prospective, nonrandomized clinical study.
Setting: Hospital-based infertility practice.