Efficacy and safety of recombinant human granulocyte colony-stimulating factor in patients with poor ovarian response: protocol for a multicentre, randomised, controlled trial.

Introduction: Approximately 17.5% of couples of reproductive age have experienced infertility. Women with a poor ovarian response (POR) must undergo in vitro fertilisation (IVF) and embryo transfer to achieve pregnancy. However, studies have reported a poor response to gonadotropin stimulation in women undergoing IVF-ET. Results from animal experiments suggest that granulocyte colony-stimulating factor (G-CSF) has a curative effect by protecting ovarian function, reducing follicle loss and delaying premature ovarian failure in rats caused by chemotherapy. Clinical studies on the therapeutic effect of G-CSF are deficient; therefore, this study will investigate its ability to improve ovum quality and maturity among women with POR undergoing IVF/intracytoplasmic sperm injection (ICSI).

Methods And Analysis: This clinical, multicentre, triple-blind, placebo-controlled trial will employ balanced randomisation (1:1). The planned sample size is 312 participants (156 subjects in each group). A total of 312 patients with infertility undergoing IVF/ICSI will be recruited from four public hospitals in China. The participants will be randomly divided into an experimental group (G-CSF) and a placebo group (control). All patients will be treated by using the progestin-primed ovarian stimulation superovulation protocol. The primary outcome will be D3 embryo quality. The number of ova obtained, MII ova and transferable embryos will be inclusive in the secondary outcome.

Ethics And Dissemination: To our knowledge, this is the first clinical trial to investigate the effect of G-CSF treatment timing and stimulation protocol in patients with POR in China. This study will provide new information about G-CSF efficacy among patients with POR undergoing IVF/ICSI and can help improve ovum quality and maturity. Clinical trials on this subject are deficient in China; therefore, a well-designed randomised trial is needed to determine the ability of G-CSF to improve ovum quality and maturity to facilitate conception among women with POR treated with IVF/ICSI.

Trial Registration Number: ChiCTR2200062412.