hCG-activated PBMC-therapy in RIF Patients
Condition: Recurrent Implantation Failure
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Peripheral Blood Monouclear Cell; Phosphate Baffer Saline
Intervention type(s): Other; Other
Intervention description(s): 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.; Only 500 microlitres PBS will be injected into the uterine cavity, instead of PBMCs, two days before embryo transfer (ET) using ET catheter.
Other intervention name(s): PBMC; PBS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Recurrent Implantation Failure; Peripheral blood mononuclear cell; Human chorionic gonadotropin