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Study aim
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Determining the effect of probiotics on fertility in women with recurrent implantation failure based on Th1 to Th2 ratio.
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Design
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Before administering the drug, heparinized blood is taken from the patients, and PBMC are isolated. Then, flow cytometry technique will be used to count the number of Th1 and Th2 cells. In order to investigate the secretion of cytokines, ELISA will be used. QRT-PCR method will be used to measure transcription factors.
After performing these steps according to the protocol, the probiotic dose (2 tablets per day) is adjusted based on the ratio of Th1 to Th2.
At this stage and after the treatment protocol, all the factors that were measured before prescribing the drug will be measured again to determine the effects of the probiotic drug on the immune system of the patients. Finally, after 9 months, in order to check the number of babies born by people with RIF, we will continuously monitor the people whose β-HCG test was positive after taking the medicine with the help of gynecologists.
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Settings and conduct
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The study will be conducted in Valiasr International Hospital, Tabriz. Subjects will receive probiotic pills according to the protocol.
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Participants/Inclusion and exclusion criteria
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Patients will be selected only from Azerbaijan people.
Patients who have experienced at least 3 consecutive implantation failures.
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Intervention groups
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The studied groups are including 3 groups of patients with RIF who receive probiotics, patients who do not receive any type of treatment despite the history of RIF problem as a control group and a group of healthy women with a history of successful pregnancy and delivery are also considered as a control group.
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Main outcome variables
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The frequency of Th1 and Th2 cells
The expression level of cytokines (IL-4, IL-10,IFNγ ,TNFα) and transcription factors (T-bet و GATA3)
Secretory levels of cytokines (IL-4, IL-10,IFNγ ,TNFα)
Pregnancy rate