InfertilityPhase 4NCT06174298
The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
A Phase 4 study testing Granulocyte Colony-Stimulating Factor (Filgrastim) and Standard Embryo Transfer Media in people with Infertility and Infertility,Female, run by Newlife Fertility Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility, Infertility,Female, Infertility; Female, Nonimplantation
- What is being tested?
- Granulocyte Colony-Stimulating Factor (Filgrastim) and Standard Embryo Transfer Media
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 20 Mar 2024to 10 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with uterine factor or severe male factor infertility will be excluded.
- Patients who have had previous IVF failures will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Newlife Fertility Centre
Mississauga, Ontario, L4Z 2G6
Samuel Soliman, M.D., +1 905-896-7100 ext. 130, drsoliman@newlifefertility.com
David Soliman, M.Sc., +1 289-242-3712, dsoliman1996@gmail.com
About this study
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)?
Read more
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).
Read the detailed description
Please see uploaded study protocol.
- Conditions
- Infertility, Infertility,Female, Infertility; Female, Nonimplantation, Infertility Unexplained, Infertility of Uterine Origin
- Being tested
- Granulocyte Colony-Stimulating Factor (Filgrastim), Standard Embryo Transfer Media
- Keywords
- Infertility, Embryo Transfer, GCSF, Granulocyte Colony-Stimulating Factor, Filgrastim, Neupogen, Implantation
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony-Stimulating Factor (Filgrastim)Drug
Also called Neupogen, 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 MediaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Embryo Transfer Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the time of birth (up to 9-months post-ET).
Secondary outcomes (2)
Spontaneous Abortion Rate
Number of patients with a confirmed clinical pregnancy who lost their pregnancy before 20 weeks of gestation divided by the total number of patients with confirmed clinical pregnancies.
Measured: From enrollment to the time of pregnancy loss (up to 20 weeks post-ET).
Biochemical Pregnancy Rate
Number of patients who had a positive beta-human chorionic gonadotropin (bhCG) pregnancy blood test at 10 days post-ET but that did not display a gestational sac/fetal heartbeat at 6-week ultrasound, divided by the total number of patients in that group.
Measured: From enrollment to the time of 6-week ultrasound.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start20 Mar 2024 (estimated)
- Primary completion10 Jan 2025 (estimated)
- Study completion10 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newlife Fertility Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Soliman, M.D., Principal investigator, Newlife Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174298
- Sponsor's protocol ID
- NFC-2023-001
- Status last verified
- Mar 2024
- First submitted
- 8 Dec 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.
PubMed 12413988Devroey P, Bourgain C, Macklon NS, Fauser BC. Reproductive biology and IVF: ovarian stimulation and endometrial receptivity. Trends Endocrinol Metab. 2004 Mar;15(2):84-90. doi: 10.1016/j.tem.2004.01.009.
PubMed 15036255Yan J, Wu K, Tang R, Ding L, Chen ZJ. Effect of maternal age on the outcomes of in vitro fertilization and embryo transfer (IVF-ET). Sci China Life Sci. 2012 Aug;55(8):694-8. doi: 10.1007/s11427-012-4357-0. Epub 2012 Aug 30.
PubMed 22932885Thum MY, Abdalla HI, Taylor D. Relationship between women's age and basal follicle-stimulating hormone levels with aneuploidy risk in in vitro fertilization treatment. Fertil Steril. 2008 Aug;90(2):315-21. doi: 10.1016/j.fertnstert.2007.06.063. Epub 2007 Oct 22.
PubMed 17953958Seshadri 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.
PubMed 32921559Tevkin S, Lokshin V, Shishimorova M, Polumiskov V. The frequency of clinical pregnancy and implantation rate after cultivation of embryos in a medium with granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with preceding failed attempts of ART. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:9-12. doi: 10.3109/09513590.2014.945767.
PubMed 25200819Sjoblom C, Wikland M, Robertson SA. Granulocyte-macrophage colony-stimulating factor promotes human blastocyst development in vitro. Hum Reprod. 1999 Dec;14(12):3069-76. doi: 10.1093/humrep/14.12.3069.
PubMed 10601098Ziebe S, Loft A, Povlsen BB, Erb K, Agerholm I, Aasted M, Gabrielsen A, Hnida C, Zobel DP, Munding B, Bendz SH, Robertson SA. A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization. Fertil Steril. 2013 May;99(6):1600-9. doi: 10.1016/j.fertnstert.2012.12.043. Epub 2013 Feb 4.
PubMed 23380186Davari-Tanha F, Shahrokh Tehraninejad E, Ghazi M, Shahraki Z. The role of G-CSF in recurrent implantation failure: A randomized double blind placebo control trial. Int J Reprod Biomed. 2016 Dec;14(12):737-742.
PubMed 28066833Eftekhar M, Miraj S, Farid Mojtahedi M, Neghab N. Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial. Int J Reprod Biomed. 2016 Nov;14(11):687-690.
PubMed 27981253Obidniak 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.
Singh R, Singh M, Jindal A, Jindal P. A prospective randomized controlled study (RCT) of Intra-uterine administration of Granulocyte Colony-Stimulating Factor (G-CSF) before embryo-transfer on resistant thin endometrium in IVF cycles. OXFORD UNIV PRESS GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND; 2015:280-280.
Barad DH, Yu Y, Kushnir VA, Shohat-Tal A, Lazzaroni E, Lee HJ, Gleicher N. A randomized clinical trial of endometrial perfusion with granulocyte colony-stimulating factor in in vitro fertilization cycles: impact on endometrial thickness and clinical pregnancy rates. Fertil Steril. 2014 Mar;101(3):710-5. doi: 10.1016/j.fertnstert.2013.12.016. Epub 2014 Jan 11.
PubMed 24424357Scarpellini F, Sbracia M. G-CSF treatment improves IVF outcome in women with recurrent implantation failure in IVF. Journal of Reproductive Immunology. 2012;1(94):103.
Aleyasin A, Abediasl Z, Nazari A, Sheikh M. Granulocyte colony-stimulating factor in repeated IVF failure, a randomized trial. Reproduction. 2016 Jun;151(6):637-42. doi: 10.1530/REP-16-0046. Epub 2016 Mar 15.
PubMed 26980809
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes
- ClinicalTrials.gov ID
- NCT06174298
- Acronym / sponsor ID
- NFC-2023-001
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Newlife Fertility CentreIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2024 (estimated)
- Primary completion
- 10 Jan 2025 (estimated)
- Study completion
- 10 Jan 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Please see uploaded study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCSF-Supplemented Embryo Transfer Media | Experimental | Drug: Granulocyte Colony-Stimulating Factor (Filgrastim)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. |
| Standard Embryo Transfer Media | Placebo comparator | Other: Standard Embryo Transfer MediaControl 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 may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with uterine factor or severe male factor infertility will be excluded.
- Patients who have had previous IVF failures will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Granulocyte Colony-Stimulating Factor (Filgrastim)Also: Neupogen, FilgrastimIntervention 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. | Drug | GCSF-Supplemented Embryo Transfer Media |
| Standard Embryo Transfer MediaControl 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. | Other | Standard Embryo Transfer Media |
Primary outcome
Implantation Rate
Time frame: From enrollment to the time of 6-week ultrasound.
Number of embryos implanted (i.e. number of gestational sacs observed under ultrasound guidance) divided by total number of embryos transferred
Clinical Pregnancy Rate
Time frame: From enrollment to the time of 6-week ultrasound.
Number of patients with fetal heartbeats detected at time of 6-week ultrasound divided by the total number of patients in that group.
Pregnancy Rate
Time frame: From enrollment to the time of blood test at 10 days post-ET.
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.
Live Birth Rate
Time frame: From enrollment to the time of birth (up to 9-months post-ET).
Total Number of infants born divided by the total number of embryo transfers performed (i.e., patients) in that group.
2 secondary outcomes
Spontaneous Abortion Rate
Time frame: From enrollment to the time of pregnancy loss (up to 20 weeks post-ET).
Biochemical Pregnancy Rate
Time frame: From enrollment to the time of 6-week ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Background: PubMed 12413988Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.
- Background: PubMed 15036255Devroey P, Bourgain C, Macklon NS, Fauser BC. Reproductive biology and IVF: ovarian stimulation and endometrial receptivity. Trends Endocrinol Metab. 2004 Mar;15(2):84-90. doi: 10.1016/j.tem.2004.01.009.
- Background: PubMed 22932885Yan J, Wu K, Tang R, Ding L, Chen ZJ. Effect of maternal age on the outcomes of in vitro fertilization and embryo transfer (IVF-ET). Sci China Life Sci. 2012 Aug;55(8):694-8. doi: 10.1007/s11427-012-4357-0. Epub 2012 Aug 30.
- Background: PubMed 17953958Thum MY, Abdalla HI, Taylor D. Relationship between women's age and basal follicle-stimulating hormone levels with aneuploidy risk in in vitro fertilization treatment. Fertil Steril. 2008 Aug;90(2):315-21. doi: 10.1016/j.fertnstert.2007.06.063. Epub 2007 Oct 22.
- Background: PubMed 32921559Seshadri 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.
- Background: PubMed 25200819Tevkin S, Lokshin V, Shishimorova M, Polumiskov V. The frequency of clinical pregnancy and implantation rate after cultivation of embryos in a medium with granulocyte macrophage colony-stimulating factor (GM-CSF) in patients with preceding failed attempts of ART. Gynecol Endocrinol. 2014 Oct;30 Suppl 1:9-12. doi: 10.3109/09513590.2014.945767.
- Background: PubMed 10601098Sjoblom C, Wikland M, Robertson SA. Granulocyte-macrophage colony-stimulating factor promotes human blastocyst development in vitro. Hum Reprod. 1999 Dec;14(12):3069-76. doi: 10.1093/humrep/14.12.3069.
- Background: PubMed 23380186Ziebe S, Loft A, Povlsen BB, Erb K, Agerholm I, Aasted M, Gabrielsen A, Hnida C, Zobel DP, Munding B, Bendz SH, Robertson SA. A randomized clinical trial to evaluate the effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) in embryo culture medium for in vitro fertilization. Fertil Steril. 2013 May;99(6):1600-9. doi: 10.1016/j.fertnstert.2012.12.043. Epub 2013 Feb 4.
- Background: PubMed 28066833Davari-Tanha F, Shahrokh Tehraninejad E, Ghazi M, Shahraki Z. The role of G-CSF in recurrent implantation failure: A randomized double blind placebo control trial. Int J Reprod Biomed. 2016 Dec;14(12):737-742.
- Background: PubMed 27981253Eftekhar M, Miraj S, Farid Mojtahedi M, Neghab N. Efficacy of Intrauterine infusion of granulocyte colony stimulating factor on patients with history of implantation failure: A randomized control trial. Int J Reprod Biomed. 2016 Nov;14(11):687-690.
- BackgroundObidniak 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.
- BackgroundSingh R, Singh M, Jindal A, Jindal P. A prospective randomized controlled study (RCT) of Intra-uterine administration of Granulocyte Colony-Stimulating Factor (G-CSF) before embryo-transfer on resistant thin endometrium in IVF cycles. OXFORD UNIV PRESS GREAT CLARENDON ST, OXFORD OX2 6DP, ENGLAND; 2015:280-280.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Soliman, M.D. principal investigator
Newlife Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granulocyte Colony-Stimulating Factor (Filgrastim) and Standard Embryo Transfer Media in people with Infertility and Infertility,Female, run by Newlife Fertility Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Soliman, M.D. (+1 905-896-7100 ext. 130, drsoliman@newlifefertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implantation Rate (time frame: From enrollment to the time of 6-week ultrasound.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06174298, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.