GCSF for Infertility

Overseen By David Soliman, M.Sc.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Newlife Fertility Centre

Disqualifiers: Uterine factor, severe male infertility, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

Duration: 1 day

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding granulocyte colony-stimulating factor (GCSF), a medication that stimulates white blood cell production, to embryo transfer media can improve success rates for individuals undergoing in vitro fertilization (IVF). Participants will receive either the standard media or the GCSF-supplemented media during the embryo transfer process. The researchers aim to determine if the GCSF addition enhances outcomes such as implantation, pregnancy, and live birth rates. Ideal participants are those in an IVF cycle, either fresh or frozen, without previous IVF failures or certain infertility issues. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering a chance to contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Granulocyte Colony-Stimulating Factor (Filgrastim)?

Research has shown that Granulocyte Colony-Stimulating Factor (GCSF), also known as Filgrastim, is generally safe for people. Studies have found that it can improve pregnancy outcomes for women undergoing in vitro fertilization (IVF). Specifically, GCSF has increased the chances of pregnancy, even for women with previous unsuccessful IVF attempts.

The FDA has approved the treatment for other uses, indicating a certain level of safety. However, while current evidence supports the safety of GCSF in IVF treatments, information on its long-term safety remains limited.

In summary, available evidence considers GCSF safe to use, but participants should discuss any concerns with their healthcare providers. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for infertility, which often focus on hormone stimulation and assisted reproductive techniques, the use of Granulocyte Colony-Stimulating Factor (GCSF) offers a novel approach by enhancing embryo transfer media. GCSF is thought to improve the uterine environment and increase implantation rates by modulating the immune system and promoting endometrial receptivity. Researchers are excited because this method could potentially enhance the success rates of embryo transfers, providing a new avenue for couples struggling with infertility.

What evidence suggests that GCSF-supplemented embryo transfer media could be effective for improving IVF outcomes?

Research has shown that Granulocyte Colony-Stimulating Factor (G-CSF) can improve pregnancy outcomes for women undergoing in vitro fertilization (IVF). In this trial, participants will join different treatment arms. One arm will receive G-CSF-supplemented embryo transfer media, which previous studies have found promising, with a success rate of 43.1% compared to 21.6% for those who did not receive it. Another study found that G-CSF increased the likelihood of pregnancy in both fresh and frozen embryo transfers. G-CSF may also assist women with a thin uterine lining, facilitating embryo implantation and leading to better pregnancy results. Overall, G-CSF has shown promise in boosting IVF success rates, especially for women who have previously struggled with implantation. ^{1 3 4 6 7}

Who Is on the Research Team?

Samuel Soliman, M.D.

Principal Investigator

Newlife Fertility Centre

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo embryo transfer with either standard or GCSF-supplemented media

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pregnancy outcomes, including implantation and live birth rates

9 months

Multiple visits (in-person and virtual) over 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Granulocyte Colony-Stimulating Factor (Filgrastim)

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10069139/

Efficacy of granulocyte colony-stimulating factor for ... G-CSF could be effective to improve the results in low responder women undergoing IVF. It may require more well-designed RCTs with larger sample ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12146186/

Effects of different granulocyte colony stimulating factor ... They reported statistically significantly higher pregnancy rates in the G-CSF group than in the control group (43.1% vs. 21.6%, p < 0.001).

3. rbej.biomedcentral.com rbej.biomedcentral.com/articles/10.1186/s12958-021-00810-4

What is the impact of granulocyte colony-stimulating factor (G ... Subgroup analysis indicated that G-CSF improved the clinical pregnancy rate for both the fresh and frozen embryo transfer cycles (fresh RR: 1.74 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S075333222200292X

Granulocyte colony-stimulating factor in reproductive ... G-CSF has been reported to improve the pregnancy outcomes of women with thin endometrium undergoing IVF. In recent years, successful application of G-CSF has ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2024.1370114/full

The value of G-CSF in women experienced at least one ... G-CSF has a beneficial effect on pregnancy outcomes to some extent among women who experienced at least one implantation failure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6984624/

Granulocyte‐colony stimulating factor administration for ... Low‐quality evidence suggests that G‐CSF administration may improve clinical pregnancy rate in women with two or more IVF failures, but the included studies had ...

7. jivfww.scholasticahq.com jivfww.scholasticahq.com/article/127965-role-of-granulocyte-colony-stimulating-factor-in-reproductive-medicine-case-series-from-uae

Role of Granulocyte Colony Stimulating Factor in ... Current evidence supports the safety and efficacy of G-CSF in improving IVF outcomes, though long-term safety data remain limited. Further ...