The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes

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).

Timeline

Start

2024-03-20

Primary completion

2025-01-10

Completion

2025-01-10

Publications

• Background 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.
• Background Devroey 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 Yan 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 Thum 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 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.
• Background Tevkin 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 Sjoblom 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 Ziebe 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 Davari-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 Eftekhar 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.
• Background 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 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.
• Background 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.
• Background Scarpellini 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.
• Background 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.
• Background Würfel W. Approaches to a better implantation. J Assist Reprod Genet. 2000;17(8):473.
• Background Rahmati M, Petitbarat M, Dubanchet S, Bensussan A, Chaouat G, Ledee N. Granulocyte-Colony Stimulating Factor related pathways tested on an endometrial ex-vivo model. PLoS One. 2014 Oct 2;9(9):e102286. doi: 10.1371/journal.pone.0102286. eCollection 2014.
• Background Cai L, Jeon Y, Yoon JD, Hwang SU, Kim E, Park KM, Kim KJ, Jin MH, Lee E, Kim H, Jeung EB, Hyun SH. The effects of human recombinant granulocyte-colony stimulating factor treatment during in vitro maturation of porcine oocyte on subsequent embryonic development. Theriogenology. 2015 Oct 15;84(7):1075-87. doi: 10.1016/j.theriogenology.2015.06.008. Epub 2015 Jun 19.
• Background Giacomini G, Tabibzadeh SS, Satyaswaroop PG, Bonsi L, Vitale L, Bagnara GP, Strippoli P, Jasonni VM. Epithelial cells are the major source of biologically active granulocyte macrophage colony-stimulating factor in human endometrium. Hum Reprod. 1995 Dec;10(12):3259-63. doi: 10.1093/oxfordjournals.humrep.a135899.
• Background Zhao Y, Rong H, Chegini N. Expression and selective cellular localization of granulocyte-macrophage colony-stimulating factor (GM-CSF) and GM-CSF alpha and beta receptor messenger ribonucleic acid and protein in human ovarian tissue. Biol Reprod. 1995 Oct;53(4):923-30. doi: 10.1095/biolreprod53.4.923.
• Background Davidson LM, Coward K. Molecular mechanisms of membrane interaction at implantation. Birth Defects Res C Embryo Today. 2016 Mar;108(1):19-32. doi: 10.1002/bdrc.21122. Epub 2016 Mar 10.
• Background Nimbkar-Joshi S, Rosario G, Katkam RR, Manjramkar DD, Metkari SM, Puri CP, Sachdeva G. Embryo-induced alterations in the molecular phenotype of primate endometrium. J Reprod Immunol. 2009 Dec;83(1-2):65-71. doi: 10.1016/j.jri.2009.08.011. Epub 2009 Oct 31.
• Background Zhang L, Xu WH, Fu XH, Huang QX, Guo XY, Zhang L, Li SS, Zhu J, Shu J. Therapeutic role of granulocyte colony-stimulating factor (G-CSF) for infertile women under in vitro fertilization and embryo transfer (IVF-ET) treatment: a meta-analysis. Arch Gynecol Obstet. 2018 Nov;298(5):861-871. doi: 10.1007/s00404-018-4892-4. Epub 2018 Sep 15.

Drugs

Indications