An interventional study of Peripheral Blood Monouclear Cell and Phosphate Baffer Saline in Recurrent Implantation Failure, sponsored by SCARM Institute, Tabriz, Iran. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-26.
Sponsored by SCARM Institute, Tabriz, Iran · Not applicable, Interventional, and Treatment
Despite the many research done in the field of infertility and in vitro fertilization (IVF), more than half of the embryos transmitted in the IVF and intracytoplasmic sperm injection (ICSI) do not implant successfully. Currently, pregnancy failure following at least three IVF/ET cycle, so that one or two high-quality embryos transmitted in each cycle is defined as recurrent implantation failure (RIF). Maternal and fetal factors can be a reason for implantation failure; maternal factors include endometrial receptivity, uterine anatomic abnormalities, and immunologic factors. Implantation failure with embryonic reasons includes genetic abnormalities and any factor that affects the implantation and growth of the embryo within the uterus. In recent years, the involvement of immune-related factors mainly natural killer cells (NK), dendritic cells (DCs), macrophages (MQ), regulatory T cells (Treg) and Th-1, in the endometrial differentiation and development and endometrial receptivity, as well as induction of immunological tolerance to the fetus, have been reported.
248 women with the history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients divided randomly into two groups, 50 patients received PBMC and 50 patients as the control group received PBS. PBMCs were obtained from patients themselves five days before embryo transfer (ET) and were cultured with hCG for 48 hours. Frothy-eight hours later, PBMCs were then administered into the uterine cavity of that patient from the study group two days before ET. PBS was inseminated into the uterine cavity of the control group instead of PBMC. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs 2, 24 and 48 hour after incubation by ELISA. The pregnancy occurrence was confirmed 12 days after ET through positive pregnancy test (β-hCG test). The success of implantation and the occurrence of clinical pregnancy were evaluated by ultrasound through the observation of the number and the location of gestational sacs at 5-6 weeks and confirming the embryo heart pulsation.
All patients were evaluated in accordance with the following inclusion and exclusion criteria;
Inclusion Criteria:
Exclusion Criteria:
Peripheral blood mononuclear cells (PBMCs) were administered into the uterine cavity of RIF patients in this group.
Other: Peripheral Blood Monouclear Cell
Phosphate buffer saline (PBS) as placebo was injected into the uterine cavity of RIF patients in this group.
Other: Phosphate Baffer Saline
Blood samples (20 mL) were taken from individual patients at the time of ovulation induction. Then PBMC were isolated and cultured (20-30 million cells) 48 hour at the presence of hCG (10IU/ml daily). Afterward,15-20 million PBMCs in 500 microlitres PBS were injected into the uterine cavity two days before embryo transfer (ET) using ET catheter.
Also known as: PBMC
Only 500 microlitres PBS will be injected into the uterine cavity, instead of PBMCs, two days before embryo transfer (ET) using ET catheter.
Also known as: PBS
pregnancy occurrence
Laboratory tests (beta-hCG test)
Time frame: "12 days after embryo transfer"
examination of inflammatory cytokines (IL-1B, TNF-a and INF-Y) secretion levels in supernatant
ELISA technique
Time frame: "48 hours after culturing"
Clinical pregnancy rate in patients with recurrent implantation failure (RIF)
detection the number and location of gestational sacs by ultrasound
Time frame: "in 5-6 weeks"
The live birth rate by patients with recurrent implantation failure (RIF)
By gynecologists and obstetricians will monitor
Time frame: "After about 9 months of positive βHCG test"
The miscarriage rate in patients with recurrent implantation failure (RIF)
By gynecologists and obstetricians will monitor
Time frame: "When ever during the pregnancy period (up to 9 months)"
Plan to share: No
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SCARM Institute, Tabriz, Iran