David H Barad1, Yao Yu2, Vitaly A Kushnir2, Aya Shohat-Tal2, Emanuela Lazzaroni2, Ho-Joon Lee2, Norbert Gleicher2. 1. The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York. Electronic address: dbarad@thechr.com. 2. The Center for Human Reproduction (CHR), New York, New York; Foundation for Reproductive Medicine, New York, New York.
Abstract
OBJECTIVE: To investigate whether granulocyte colony-stimulating factor (G-CSG) affects endometrial thickness, implantation rates, and clinical pregnancy rates in routine, unselected IVF cycles. DESIGN: Registered, individually randomized, two-group, parallel double-blinded placebo-controlled clinical trial. SETTING: Academically affiliated private clinical and research center. PATIENT(S): 141 consecutive, unselected, consenting women with no history of renal disease, sickle cell disease, or malignancy who were undergoing IVF. INTERVENTION(S): Sealed, numbered, opaque envelopes assigned 73 patients to receive G-CSF (Filgrastim, Amgen, 300 μg/1.0 mL) and 68 to receive placebo (saline). MAIN OUTCOME MEASURE(S): Endometrial thickness, clinical pregnancy, and embryo implantation rates. RESULT(S): The mean age for the whole study group was 39.59 ± 5.56 years (G-CSF: 39.79 ± 5.13 years; placebo: 39.38 ± 6.03 years). Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm. The increase in the G-CSF group was not statistically significantly different from the control group. Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment. There were no adverse events for either treatment group. CONCLUSION(S): In normal IVF patients, G-CSF does not affect endometrial thickness, implantation rates, or clinical pregnancy rates. Because these results were obtained in an older patient population, they may not necessarily apply to younger women. CLINICAL TRIAL REGISTRATION NUMBER: NCT01202656.
RCT Entities:
OBJECTIVE: To investigate whether granulocyte colony-stimulating factor (G-CSG) affects endometrial thickness, implantation rates, and clinical pregnancy rates in routine, unselected IVF cycles. DESIGN: Registered, individually randomized, two-group, parallel double-blinded placebo-controlled clinical trial. SETTING: Academically affiliated private clinical and research center. PATIENT(S): 141 consecutive, unselected, consenting women with no history of renal disease, sickle cell disease, or malignancy who were undergoing IVF. INTERVENTION(S): Sealed, numbered, opaque envelopes assigned 73 patients to receive G-CSF (Filgrastim, Amgen, 300 μg/1.0 mL) and 68 to receive placebo (saline). MAIN OUTCOME MEASURE(S): Endometrial thickness, clinical pregnancy, and embryo implantation rates. RESULT(S): The mean age for the whole study group was 39.59 ± 5.56 years (G-CSF: 39.79 ± 5.13 years; placebo: 39.38 ± 6.03 years). Endometrial thickness statistically significantly increased over the 5-day observation period for the whole group by approximately 1.36 mm. The increase in the G-CSF group was not statistically significantly different from the control group. Statistical models looking at treatment effects on clinical pregnancy and implantation rates demonstrated no effect of G-CSF treatment. There were no adverse events for either treatment group. CONCLUSION(S): In normal IVFpatients, G-CSF does not affect endometrial thickness, implantation rates, or clinical pregnancy rates. Because these results were obtained in an older patient population, they may not necessarily apply to younger women. CLINICAL TRIAL REGISTRATION NUMBER: NCT01202656.