The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment. The main question it aims to answer is: Can in vitro fertilization-embryo transfer (IVF-ET) outcomes be improved by supplementing the transfer media with Granulocyte colony-stimulating factor (GCSF)? Participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the GCSG-supplemented transfer media. Researchers will compare the GCSF and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).
Please see uploaded study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
300
Intervention Group Fresh Embryo Transfers: On day 5 or 6 of culture, viable embryos will be transferred into a center-well dish containing 1 mL of embryo transfer media supplemented with GCSF. The embryos will be cultured in this medium for approximately 3 hours before the embryo transfer (ET) procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician. Intervention Group Frozen Embryo Transfers: Cryopreserved embryos will be thawed according to the Kitazato thawing protocol and will be subsequently transferred to a center-well dish containing 1 mL of embryo transfer media supplemented with GCSF. The embryos will be cultured in this medium for approximately 3 hours before the ET procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician.
Control Group Fresh Embryo Transfers: On day 5 or 6 of culture, viable embryos will be transferred into a center-well dish containing 1 mL of embryo transfer media. The embryos will be cultured in this medium for approximately 3 hours before the embryo transfer (ET) procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician. Control Group Frozen Embryo Transfers: Cryopreserved embryos will be thawed according to the Kitazato thawing protocol and will be subsequently transferred to a center-well dish containing 1 mL of embryo transfer media. The embryos will be cultured in this medium for approximately 3 hours before the ET procedure. During the ET procedure, the same media will be used to fill the ET syringe and catheter that will be used to deposit the embryos into the uterus by the physician.
Newlife Fertility Centre
Mississauga, Ontario, Canada
RECRUITINGImplantation Rate
Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred
Time frame: From enrollment to the time of 6-week ultrasound.
Clinical Pregnancy Rate
Number of patients with fetal heartbeats detected at time of 6-week ultrasound divided by the total number of patients in that group.
Time frame: From enrollment to the time of 6-week ultrasound.
Pregnancy Rate
Number of patients with a positive beta-human chorionic gonadotropin (bhCG) pregnancy blood test at 10 days post-ET divided by the total number of patients in that group.
Time frame: From enrollment to the time of blood test at 10 days post-ET.
Live Birth Rate
Total Number of infants born divided by the total number of embryo transfers performed (i.e., patients) in that group.
Time frame: From enrollment to the time of birth (up to 9-months post-ET).
Spontaneous Abortion Rate
Number of patients with a confirmed clinical pregnancy who lost their pregnancy before 20 weeks of gestation divided by the total number of patients with confirmed clinical pregnancies.
Time frame: From enrollment to the time of pregnancy loss (up to 20 weeks post-ET).
Biochemical Pregnancy Rate
Number of patients who had a positive beta-human chorionic gonadotropin (bhCG) pregnancy blood test at 10 days post-ET but that did not display a gestational sac/fetal heartbeat at 6-week ultrasound, divided by the total number of patients in that group.
Time frame: From enrollment to the time of 6-week ultrasound.
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