DOUBLE-BLIND PLACEBO-CONTROLLED STUDY - HUMAN BIOSYNTHETIC GROWTH-HORMONE FOR ASSISTED REPRODUCTIVE TECHNOLOGY

Objective: To study whether the effect of cotreatment with human biosy nthetic GH improves the outcome of poor IVF responders. Design: A doub le-blind placebo-controlled study using a GnRH agonist (GnRH-a) and go nadotropin in a ''boost'' flare-up protocol for ovarian stimulation to gether with either placebo, 4, or 12 IU of human GH followed by oocyte retrieval and IVF-ET. Patients: Twenty-two patients with previously d emonstrated poor responses in at least two assisted reproductive techn ology cycles were recruited. Interventions: Pretreatment and post-trea tment blood samples and daily morning blood samples during ovarian sti mulation were collected after an overnight fast. Human GH or placebo a nd GnRH-a were administered SC; gonadotropin was administered IM. Oocy tes were collected by ultrasound-guided transvaginal aspiration of fol licles. Embryos were cultured in vitro and transferred transcervically . Main Outcome Measures: Serum E(2), FSH, GH, insulin-like growth fact or-I (IGF-I), IGF binding protein 1 (IGFBP-1), and IGFBP-3 concentrati ons. Number of FSH ampules, follicles, oocytes, embryos, and pregnanci es. Results: No improvement in cycle outcome was demonstrated with dai ly adjuvant human GH administration with either 4 or 12 IU. Serum IGF- I levels were highest in the 12 IU human GH group and lowest in the pl acebo group. Serum IGFBP-3 levels increased 2 days after IGF-I levels in the 12 IU human GH group only. Serum IGFBP-1 levels were unchanged in all groups. Conclusion: Poor IVF responders do not benefit from cot reatment with human GH during their ovarian stimulation.