The Effects of Lymphocyte Therapy on Pregnancy Rate of Patient With Recurrent Implantation Failure

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: Female

Summary

Infertility and miscarriage ordinary events in reproductive failure in humans, as are affected one couple in every six couples of reproductive age and abortion is including in approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains below 30% and Recurrent Implantation Failure in one of the most important limiting factor is the assisted reproductive techniques. According to studies conducted in recent years one of the most important mechanisms of implantation failure is maternal immune system because the fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly associated with implantation failure. Lymphocytes during implantation, in association with endometrium and blastocyst, participate in the production of cytokines, in particular Th1 pre-inflammatory cytokines. TNFα, IFNγ ،LIF ،IL12 ،IL15 Among these are pre-inflammatory cytokines that appear to be necessary in the early stages of implantation. The initial inflammatory response should therefore be selectively reduced to preserve pregnancy. Inflammatory response impairment at the beginning of pregnancy causes fetal implantation failure, while high inflammation leads to acute rejection (spontaneous abortion) or chronic (pre-eclampsia) ). Preserving pregnancy requires a specific cytokine pattern, in particular Th2 cytokines (IL3, IL4, IL5, IL10, IL13, GMCSF), which causes the anti-inflammatory state of pregnancy required. Therefore, maternal immunity seems to be involved in creating and sustaining pregnancy through the Th1 / Th2 Thalassic Balance. An imbalance between the two systems can be an explanation for the implantation failure in some patients. The effect of intra-uterine lymphocyte therapy on the fertility rate of women with RIF in the mouse model has been shown to be controlled by the Th1 system. While the Th2 system has a protective role, two thirds of patients have had an incomplete endometrial admission. Since the immune cells of the uterus are balanced through a broad cytokine pattern, it is important to evaluate the implantation success of RIF patients after intrauterine insemination (IUI) of their own lymphocytes in the uterus in the pre-implantation phase. Laboratory tests on mice show an increase in the number of embryonic implantations with human PMBCs. Considering the importance of TH1 and TH2 cells in the success or failure of pregnancy and the relationship between the function and balance of these cells with pregnancy problems, such as implantation failure (RIF), and the role of factors and inflammatory cytokines in creating proper nesting conditions, by introducing the lymphocytes of a participants infected with RIF into the uterus in order to induce primary inflammation, the investigators will examine its effect on fertility and the success of implantation in women with RIF.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: SCARM Institute, Tabriz, Iran
• Last Updated: 2017-08-29

Criteria

Inclusion Criteria:

The patients selected for this study will be one or a number of immunological disorders are the following:

1. At least have three implantation failures following IVF

2. Have primary infertility

3. The thickness of the endometrium on the day of ovulation induction with HCG is less than 6 mm

4. Age of people under 40 years

5. Have regular menstruation cycles

6. BMI is under 30

7. There is no uterus pathology.

Exclusion Criteria:

1. Having polycystic ovary syndrome

2. The presence of any uterine pathology

3. Save ovarian weakness

4. Chromosomal abnormalities

5. Anti-phospholipid antibody

6. The presence of mutations involving the coagulation system, such as Factor Factor XII, Pro C, Pro S

7. Patients who are positive for their HIV, HCV, or HBV test.