Granulocyte colony stimulating factor (GCSF) did not affect the fertility outcomes in women with unexplained infertility after intrauterine insemination: a randomised clinical trial

Abstract

This study aimed to evaluate the effect of granulocyte colony stimulating factor (GCSF) on fertility outcomes in women with unexplained infertility after intrauterine insemination (IUI). This study is a randomised clinical trial that was conducted on unexplained infertile women referred to infertility Clinic in Yasuj, Iran. All participants were stimulated by letrozole, clomiphene and HMG during the cycle. When at least one follicle was greater than 18 mm, 5000 IU hCG intramuscularly was administered for ovulation induction and then IUI was performed 34–36 hours later. In GCSF group, 300 μg GCSF subcutaneously administrated in two days after IUI. Control group received routine IUI. The main outcome measures were biochemical pregnancy, clinical pregnancy, abortion and ongoing pregnancy rate. Our results showed no statistically significant difference in the biochemical pregnancy (16.3% vs. 12.2%; P=.56), clinical pregnancy (16.3% vs. 8.2%; P=.21), abortion (0 vs. 2.04%; P=.55) and ongoing pregnancy rates (8.2% vs. 14.2%; P=.32) between the control and the G-CSF groups. The results of the current study suggest that systemic administration of 300 μg GCSF in the two days after receiving IUI in patients with unexplained infertility does not offer any beneficial clinical related implantation, and pregnancy rates. IRCT registration number: IRCT20160524028038N4

Impact statement

• What is already known on this subject? Unexplained infertility means to the inability of couples in pregnancy after a year without obvious male and female infertility factors. Some patients have not been justified in endometrial function, which leads to the defect of the dialogue between the foetus and endometrium and may lead to implantation failure. Granulocyte colony stimulating factor is produced at the maternal-foetal interface during embryo implantation and is the main part of the uterine-cytokine network that is needed to create and maintain pregnancy.

• What do the results of this study add? The current study suggests that systemic administration of 300 μg granulocyte colony stimulating factor in the two days after receiving IUI in patients with unexplained infertility does not offer any beneficial clinical related implantation and pregnancy rates.

• What are the implications of these findings for clinical practice and/or further research? These results may not be generalised to all patients and more randomised controlled trials are needed for the comparison of granulocyte colony stimulating factor effects on women with thin and normal endometrial thickness, efficacy, side effects, and pregnancy outcomes of the intrauterine perfusion versus systemic subcutaneous administration of granulocyte colony stimulating factor in unexplained infertility treated with intrauterine insemination.

Keywords:

• Endometrium
• GCSF
• IUI
• unexplained infertility

Ethics approval and consent to participate

All procedures in the current study were in accordance with the ethical standards of Yasuj university of Medical sciences with the 1964 Helsinki declaration. The Ethics Committee of the Yasuj University of Medical Sciences, Yasuj, Iran, approved the study, by reference number: IR.YUMS.REC.1397.122. This study was conducted in 2019. Written informed consent was obtained from all participating. This study was registered prospectively at the Iranian Registry of Clinical Trials (www.irct.ir). Trial registration: IRCT, IRCT20160524028038N4. Prospectively registered since 03/06/2019, https://www.irct.ir/trial/39855.

Author contributions

SH. A, M. AK, F. N, P.GH, R.V, SA. T contributed in conception, design and drafting of the manuscript. SH.A, M.AK,F.N contributed in data collection. SH.A and SA.T contributed in manuscript drafting. All authors approved the final version for submission. SH.A and SA.T oversaw the study.

Disclosure statement

The authors have no conflict of interest in this manuscript.

Data availability statement

The datasets generated and/or analysed during the current study are not publicly available due to personal data protection legislation but are available from the corresponding author on reasonable request.

Additional information

Funding

This study was funded by a grant from Yasuj University of Medical Sciences (grant number: 960219).