GCSF for Infertility

Overseen By David Soliman, M.Sc.

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Newlife Fertility Centre

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Samuel Soliman, M.D.

Principal Investigator

Newlife Fertility Centre

Eligibility Criteria

This trial is for women with unexplained infertility who are undergoing in vitro fertilization (IVF). It includes those having fresh embryo transfers or frozen embryo transfers. Women with uterine issues, severe male factor infertility, or multiple IVF failures cannot participate.

Inclusion Criteria

I am undergoing IVF and will have embryo transfer in the same or a future cycle.

Exclusion Criteria

Patients with uterine factor or severe male factor infertility will be excluded.

Patients who have had previous IVF failures will be excluded.

Treatment Details

Interventions

• Granulocyte Colony-Stimulating Factor (Filgrastim) (Cytokine)

Trial Overview The study tests if adding Granulocyte Colony-Stimulating Factor (G-CSF) to the standard embryo transfer media improves IVF outcomes like implantation and pregnancy rates. Participants will be randomly assigned to receive either the G-CSF supplemented media or the standard one during their transfer.

Participant Groups

Group I: GCSF-Supplemented Embryo Transfer Media Experimental Treatment 1 Intervention

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 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. 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 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.

Group II: Standard Embryo Transfer Media Placebo Group 1 Intervention

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 standard 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 standard 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.

Who Is Running the Clinical Trial?

Newlife Fertility Centre

Lead Sponsor

Trials

1

Recruited

300+