Recruiting

Granulocyte Colony Stimulating Factor

Sponsor:

Newlife Fertility Centre

Code:

NCT06174298

Conditions

Infertility

Infertility,Female

Infertility; Female, Nonimplantation

Infertility Unexplained

Infertility of Uterine Origin

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Not accepted

Interventions

Granulocyte Colony-Stimulating Factor (Filgrastim)

Standard Embryo Transfer Media

Study Details

Brief summary:

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).

Conditions

Infertility

Infertility,Female

Infertility; Female, Nonimplantation

Infertility Unexplained

Infertility of Uterine Origin

Study ID

NCT06174298

Start date

Mar 20, 2024

Status verified date

Mar, 2024

Completion date

Jan 10, 2025

Anticipated

Primary completion date

Jan 10, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Recruited subjects will either be undergoing a fresh IVF-ET cycle in which the embryo(s) generated from the initial treatment cycle are transferred during that same cycle (i.e., on day 5 or 6 post-egg retrieval) or an FET cycle in which the embryo(s) transferred were generated in a previous IVF cycle and were cryopreserved for subsequent warming and transfer.

Exclusion Criteria:

  • Patients with uterine factor or severe male factor infertility will be excluded.
  • Patients who have had previous IVF failures will be excluded.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: GCSF-Supplemented Embryo Transfer Media

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.

placebo comparator: Standard Embryo Transfer Media

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.

Interventions

Granulocyte Colony-Stimulating Factor (Filgrastim)

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.

Standard Embryo Transfer Media

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.

Primary outcome measure

  • Implantation Rate [ Time Frame: From enrollment to the time of 6-week ultrasound. ]
  • Clinical Pregnancy Rate [ Time Frame: From enrollment to the time of 6-week ultrasound. ]
  • Pregnancy Rate [ Time Frame: From enrollment to the time of blood test at 10 days post-ET. ]
  • Live Birth Rate [ Time Frame: From enrollment to the time of birth (up to 9-months post-ET). ]

Central Contacts and Locations

Central contacts

Samuel Soliman, M.D.

+1 905-896-7100drsoliman@newlifefertility.com

David Soliman, M.Sc.

+1 289-242-3712dsoliman1996@gmail.com

Locations

Newlife Fertility Centre

Recruiting

Mississauga, Ontario, Canada, L4Z 2G6

Contacts

Samuel Soliman, M.D.

+1 905-896-7100drsoliman@newlifefertility.com

David Soliman, M.Sc.

+1 289-242-3712dsoliman1996@gmail.com

Principal Investigator:

Samuel Soliman, M.D.

More Information

Sponsor

Newlife Fertility Centre

Last update posted

Mar 21, 2024

Last verified

Mar, 2024

Keywords

  • Infertility
  • Embryo Transfer
  • GCSF
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • Neupogen
  • Implantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Newlife Fertility Centre on 2024-03-21.