The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes

NCT06174298 | Recruiting Phase 4

• 1 other identifier: NFC-2023-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Implantation Rate

  Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred

  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.

  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.

  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.

  From enrollment to the time of birth (up to 9-months post-ET).

Secondary Outcomes (2)

• Spontaneous Abortion Rate

  From enrollment to the time of pregnancy loss (up to 20 weeks post-ET).

• Biochemical Pregnancy Rate

  From enrollment to the time of 6-week ultrasound.

Study Arms (2)

GCSF-Supplemented Embryo Transfer Media

EXPERIMENTAL

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.

Drug: Granulocyte Colony-Stimulating Factor (Filgrastim)

Standard Embryo Transfer Media

PLACEBO COMPARATOR

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.

Other: Standard Embryo Transfer Media

Interventions

Granulocyte Colony-Stimulating Factor (Filgrastim) DRUG

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.

Also known as: Neupogen, Filgrastim

GCSF-Supplemented Embryo Transfer Media

Standard Embryo Transfer Media OTHER

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.

Standard Embryo Transfer Media

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: Biological Females (cisgender women)
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Newlife Fertility Centre: lead

Study Sites (1)

Newlife Fertility Centre

Mississauga, Ontario, L4Z 2G6, Canada

RECRUITING

Related Publications (23)

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• Seshadri S, Morris G, Serhal P, Saab W. Assisted conception in women of advanced maternal age. Best Pract Res Clin Obstet Gynaecol. 2021 Jan;70:10-20. doi: 10.1016/j.bpobgyn.2020.06.012. Epub 2020 Aug 7.

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• Obidniak D, Gzgzyan A, Dzhemlikhanova L, Feoktistov A. Effect of colony-stimulating growth factor on outcome of frozen-thawed embryo transfer in patients with repeated implantation failure. Fertility and Sterility. 2016;106(3):e134-e135.

  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Infertility; Infertility, Female

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Samuel Soliman, M.D.

  Newlife Fertility Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Soliman, M.D.

CONTACT

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

David Soliman, M.Sc.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: March 20, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)