Infertility Clinical Trial
Official title:
Intrauterine Infusion of Granulocyte Colony Stimulating Factor and Reproductive Outcomes in Infertile Women With History of Recurrent Implantation Failure
Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure
Status | Recruiting |
Enrollment | 100 |
Est. completion date | November 30, 2023 |
Est. primary completion date | October 30, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | Inclusion Criteria: 1. Age group (18-38) 2. History of at least 2 previous IVF or ICSI trial failures with ET of at least 2 good quality embryos in each trial. 3. Endometrial cavity within normal anatomy as assessed with transvaginal ultrasound (TV-US) with or without hysteroscopy and HSG if needed. 4. Availability of good quality embryos (at least 2 grade A embryos) for ET in the investigated trial Exclusion Criteria: Any factor which may affect quality of embryos transferred or endometrial receptivity and embryo growth, like: 1. Severe male factor infertility 2. Poor ovarian reserve (according to ESHRE criteria) 1 3. Uterine anatomic factor (eg polyp, intramural fibroid, endometrial septum, intrauterine synechiae .. etc) as well as endometritis 4. Immunological disorder (eg: SLE, APS, … etc) 5. Thyroid or adrenal dysfunction 6. Thrombophilia history or tendency as proven by labs in suspected women 7. Untreated hyperprolactinemia 8. Genetic abnormalities in the infertile couple 9. Chronic hematologic, renal or liver disease |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo university Kasr Alainy OBGYN hospital | Cairo | AlQuahira |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Arefi S, Fazeli E, Esfahani M, Borhani N, Yamini N, Hosseini A, Farifteh F. Granulocyte-colony stimulating factor may improve pregnancy outcome in patients with history of unexplained recurrent implantation failure: An RCT. Int J Reprod Biomed. 2018 May;16(5):299-304. — View Citation
Bashiri A, Halper KI, Orvieto R. Recurrent Implantation Failure-update overview on etiology, diagnosis, treatment and future directions. Reprod Biol Endocrinol. 2018 Dec 5;16(1):121. doi: 10.1186/s12958-018-0414-2. — View Citation
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. — View Citation
Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19. — View Citation
Gleicher N, Kim A, Michaeli T, Lee HJ, Shohat-Tal A, Lazzaroni E, Barad DH. A pilot cohort study of granulocyte colony-stimulating factor in the treatment of unresponsive thin endometrium resistant to standard therapies. Hum Reprod. 2013 Jan;28(1):172-7. doi: 10.1093/humrep/des370. Epub 2012 Oct 18. — View Citation
Gleicher N, Vidali A, Barad DH. Successful treatment of unresponsive thin endometrium. Fertil Steril. 2011 May;95(6):2123.e13-7. doi: 10.1016/j.fertnstert.2011.01.143. Epub 2011 Feb 16. — View Citation
Kahyaoglu I, Yilmaz N, Timur H, Inal HA, Erkaya S. Granulocyte colony-stimulating factor: A relation between serum and follicular fluid levels and in-vitro fertilization outcome in patients with polycystic ovary syndrome. Cytokine. 2015 Jul;74(1):113-6. doi: 10.1016/j.cyto.2014.09.002. Epub 2014 Sep 23. — View Citation
Li J, Mo S, Chen Y. The effect of G-CSF on infertile women undergoing IVF treatment: A meta-analysis. Syst Biol Reprod Med. 2017 Aug;63(4):239-247. doi: 10.1080/19396368.2017.1287225. Epub 2017 Feb 28. — View Citation
Meier P, Gloekler S, Oezdemir B, Indermuehle A, Traupe T, Vogel R, de Marchi S, Seiler C. G-CSF induced arteriogenesis in humans: molecular insights into a randomized controlled trial. Curr Vasc Pharmacol. 2013 Jan;11(1):38-46. — View Citation
Rahmati M, Petitbarat M, Dubanchet S, Bensussan A, Chaouat G, Ledee N. Colony Stimulating Factors 1, 2, 3 and early pregnancy steps: from bench to bedside. J Reprod Immunol. 2015 Jun;109:1-6. doi: 10.1016/j.jri.2015.01.005. Epub 2015 Feb 11. — View Citation
Reda A, Hamid AS, Mostafa R, Refaei E. Comparison between findings of saline infusion sonohysterography and office hysteroscopy in patients with recurrent implantation failure. J Hum Reprod Sci. 2016 Oct-Dec;9(4):236-240. doi: 10.4103/0974-1208.197661. — View Citation
Sugita K, Hayakawa S, Karasaki-Suzuki M, Hagiwara H, Chishima F, Aleemuzaman S, Li JA, Nishinarita S, Yamamoto T. Granulocyte colony stimulation factor (G-CSF) suppresses interleukin (IL)-12 and/or IL-2 induced interferon (IFN)-gamma production and cytotoxicity of decidual mononuclear cells. Am J Reprod Immunol. 2003 Jul;50(1):83-9. doi: 10.1034/j.1600-0897.2003.00024.x. — View Citation
Xu B, Zhang Q, Hao J, Xu D, Li Y. Two protocols to treat thin endometrium with granulocyte colony-stimulating factor during frozen embryo transfer cycles. Reprod Biomed Online. 2015 Apr;30(4):349-58. doi: 10.1016/j.rbmo.2014.12.006. Epub 2014 Dec 30. — View Citation
* Note: There are 13 references in all — Click here to view all references
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Primary | Clinical pregnancy rate | (GS with viable embryo 4 weeks after ET) | 4 weeks after ET |
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