Intrauterine Infusion of GCSF and Reproductive Outcomes in Infertile Women with History of RIF

NCT04998279 | Completed

• 1 other identifier: 2464949
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Intrauterine infusion of granulocyte colony stimulating factor and reproductive outcomes in infertile women with history of recurrent implantation failure

Conditions

Recurrent Implantation Failure; Granulocyte Colony-Stimulating Factor; Infertility

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate

  (GS with viable embryo 4 weeks after ET)

  4 weeks after ET

Study Arms (2)

Intervention group

Drug: Granulocyte Colony-Stimulating Factor

Control group

Other: placebo

Interventions

Granulocyte Colony-Stimulating Factor DRUG

Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation

Also known as: filgrastim

Intervention group

placebo OTHER

mock test without injection of G-CSF

Control group

Eligibility Criteria

• Age: 18 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Infertility patients undergoing ICSI trials at Cairo university school of Medicine IVF unit.

You may qualify if:

• Age group (18-38)
• History of at least 2 previous IVF or ICSI trial failures with ET of at least 2 good quality embryos in each trial.
• Endometrial cavity within normal anatomy as assessed with transvaginal ultrasound (TV-US) with or without hysteroscopy and HSG if needed.
• Availability of good quality embryos (at least 2 grade A embryos) for ET in the investigated trial

You may not qualify if:

• Any factor which may affect quality of embryos transferred or endometrial receptivity and embryo growth, like:
• Severe male factor infertility
• Poor ovarian reserve (according to ESHRE criteria) 1
• Uterine anatomic factor (eg polyp, intramural fibroid, endometrial septum, intrauterine synechiae .. etc) as well as endometritis
• Immunological disorder (eg: SLE, APS, … etc)
• Thyroid or adrenal dysfunction
• Thrombophilia history or tendency as proven by labs in suspected women
• Untreated hyperprolactinemia
• Genetic abnormalities in the infertile couple
• Chronic hematologic, renal or liver disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Kasr Alainy OBGYN hospital

Cairo, AlQuahira, Egypt

Location

Related Publications (14)

• 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.

  PMID: 21505041 BACKGROUND

• 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.

  PMID: 30518389 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.

  PMID: 27981253 BACKGROUND

• 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.

  PMID: 28216911 BACKGROUND

• 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.

  PMID: 30027145 BACKGROUND

• 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.

  PMID: 25258001 BACKGROUND

• 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.

  PMID: 14506932 BACKGROUND

• 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.

  PMID: 25721620 BACKGROUND

• 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.

  PMID: 23391421 BACKGROUND

• 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.

  PMID: 21324451 BACKGROUND

• 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.

  PMID: 23081869 BACKGROUND

• 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.

  PMID: 25682303 BACKGROUND

• 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.

  PMID: 28632452 BACKGROUND

• Elkhateb I, Fahmy R, Ramadan W, Mourad A, El-Demiry NM, Shohayeb A. Granulocyte colony-stimulating factor for recurrent implantation failure: the results of a 5-years cohort study. Sci Rep. 2025 Nov 18;15(1):40390. doi: 10.1038/s41598-025-24587-3.

  PMID: 41254175 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 10, 2021
• Study Start: September 1, 2019
• Primary Completion: August 30, 2024
• Study Completion: September 25, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

EG (1)