Double-blind placebo controlled study: human biosynthetic growth hormone for assisted reproductive technology

Abstract

Objective: To study whether the effect of cotreatment with human biosynthetic GH improves the outcome of poor IVF responders.

Design: A double-blind placebo-controlled study using a GnRH agonist (GnRH-a) and gonadotropin in a "boost" flare-up protocol for ovarian stimulation together with either placebo, 4, or 12 IU of human GH followed by oocyte retrieval and IVF-ET.

Patients: Twenty-two patients with previously demonstrated poor responses in at least two assisted reproductive technology cycles were recruited.

Interventions: Pretreatment and post-treatment blood samples and daily morning blood samples during ovarian stimulation were collected after an overnight fast. Human GH or placebo and GnRH-a were administered SC; gonadotropin was administered IM. Oocytes were collected by ultrasound-guided transvaginal aspiration of follicles. Embryos were cultured in vitro and transferred transcervically.

Main outcome measures: Serum E2, FSH, GH, insulin-like growth factor-I (IGF-1), IGF binding protein 1 (IGFBP-1), and IGFBP-3 concentrations. Number of FSH ampules, follicles, oocytes, embryos, and pregnancies.

Results: No improvement in cycle outcome was demonstrated with daily 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 placebo 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 cotreatment with human GH during their ovarian stimulation.