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Cytokine

GCSF-Supplemented Embryo Transfer Media 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

Study 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.Check my eligibility

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.See study design

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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to the time of birth (up to 9-months post-et). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical Pregnancy Rate

Implantation Rate

Live Birth Rate

+1 more

Secondary outcome measures

Biochemical Pregnancy Rate

Spontaneous Abortion Rate

Side effects data

From 2014 Phase 3 trial • 118 Patients • NCT00003138

31%

Fatigue

23%

Pulmonary

15%

Infection

Cardiac adverse event

Diarrhea

Esophagitis

Hot flashes

Other toxicities

Hemorrhage

Skin

Weight loss

Neuropathy-clinical

Edema

Anemia

Neuropathy-psych

Abdominal cramps

100%

80%

60%

40%

20%

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)

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Newlife Fertility CentreLead Sponsor

Samuel Soliman, M.D.Principal InvestigatorNewlife Fertility Centre

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experimental protocol admit participants aged 25 and above?

"This medical study requires participants to be aged between 18 and 38. Simultaneously, there exist 17 clinical trials for minors and another 38 studies targeting individuals over 65 years old."

Answered by AI

Is it possible to join the current clinical trial?

"Those hoping to be accepted into this medical research should have infertility and an age between 18-38 years old. In total, the trial is looking for 300 volunteers."

Answered by AI

Does the Food and Drug Administration recognize GCSF-Supplemented Embryo Transfer Media as a legitimate treatment?

"As this medical treatment is approved and Phase 4 of the trial has been reached, GCSF-Supplemented Embryo Transfer Media was granted a score of 3 on the safety scale."

Answered by AI

Is this clinical research open to new participants?

"Sadly, the clinical trial is not presently seeking participants. The research was first posted on October 1st 2024 and last modified on August 12th 2023. Fortunately, there are currently 259 other studies that are open to enrolment for test subjects."

Answered by AI

Who else is applying?

What site did they apply to?

Newlife Fertility Centre

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

Why did patients apply to this trial?

I have had three failed IUI cycles and I am not on speaking terms with my fertility doctor because I got mad at him for suggesting IVF because he said originally we would do six and wanted to stop at three. He said maybe my tubes were blocked and shot me down when I asked for testing to prove or disprove that. I was with New Life Fertility, but I am unwilling to deal with them because of my negative experience with them.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes

2024. "The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06174298.

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