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Cytokine
GCSF for Infertility
Phase 4
Recruiting
Led By Samuel Soliman, M.D.
Research Sponsored by Newlife Fertility Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to the time of birth (up to 9-months post-et).
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial seeks to see if adding GCSF to embryo transfer media can improve IVF success rates.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly stated here, potential side effects of G-CSF may include bone pain, headache, nausea, and redness at injection site. However, since it's added to transfer media and not injected directly into participants these specific side effects might differ.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from enrollment to the time of birth (up to 9-months post-et).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to the time of birth (up to 9-months post-et).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Pregnancy Rate
Implantation Rate
Live Birth Rate
+1 moreSecondary study objectives
Biochemical Pregnancy Rate
Spontaneous Abortion Rate
Side effects data
From 2014 Phase 3 trial • 118 Patients • NCT0000313831%
Fatigue
23%
Pulmonary
15%
Infection
8%
Cardiac adverse event
8%
Diarrhea
8%
Esophagitis
8%
Hot flashes
8%
Other toxicities
8%
Hemorrhage
8%
Skin
8%
Weight loss
8%
Neuropathy-clinical
8%
Edema
8%
Anemia
8%
Neuropathy-psych
8%
Abdominal cramps
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erythropoietin (300 Units/kg) and Filgrastim (Step 4)
Supportive Care (Step 1)
Erythropoietin (Step 1)
Erythropoietin (Cross-over; Step 2)
Erythropoietin (150 Units/kg) and Filgrastim (Step 3)
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: GCSF-Supplemented Embryo Transfer MediaExperimental Treatment1 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 MediaPlacebo Group1 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.
Find a Location
Who is running the clinical trial?
Newlife Fertility CentreLead Sponsor
Samuel Soliman, M.D.Principal InvestigatorNewlife Fertility Centre