Unexplained Recurrent Miscarriage and Recurrent Implantation Failure
Conditions
Keywords
uRM, RIF, Th1, Th2, Treg, lymphocyte immunotherapy
Brief summary
Recurrent miscarriage(RM) and recurrent implantation failure (RIF) are clinical challenge for clinicians and patients who are desperate for a healthy child.The specific etiology contains chromosomal abnormalities, reproductive anatomical abnormalities, endocrine disorders, reproductive system infections, autoimmune and environmental factors. However there are still 50% to 60% RM and RIF which don't have a clear cause,mainly associated with alloimmune factors.Among various treatments,lymphocytes active immunotherapy is the most common treatment method, and its clinical efficacy is widely recognized although its action mechanism is not clear so far.
Detailed description
The main mechanism of active immunotherapy includes upregulating Th2-type cytokines, downregulating Th1-type cytokines, making Th1 / Th2 shift to Th2, inducing maternal serum IL-6 and sIL6R, PIBF, EGF; inducing the expression of Fas / Fasl on lymphocyte surface; increasing the proportion of CD8 + cells, Th2-type cells and CD + CD25 + Treg cells, decreasing the activity of CD56 + CD16 + NK cell and so on.The purpose of this study is to observe the treatment effects of active immunotherapy on uRM and RIF patients. What's more,we will used flow cytometry, and quantitative real-time PCR (qPCR) methods to characterize Th1、Th2 and Treg cell populations after immunotherapy,ecpecting to find out the exact molecule mechanism of immunotherapy with paternal or third party lymphocytes.
Interventions
PROCEDURElow-dose lymphocyte immunotherapy
Peripheral venous blood (PBMCs) was drawn from the husbands of uRM and RIF patients and then the PBMCs were resuspended and administered intradermally to uRM and RIF patients 3 times at 3-week intervals. Once conceived, the uRM and RIF patients undergo 2 rounds of treatment at 8-week intervals.
Sponsors
Nanjing University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy except for their history of recurrent abortions and were negative for blocking antibodies * Willing to receive follow up
Exclusion criteria
* Patients with genetic impairment * Patients with Mullerian anomaly * Patients with hormonal deficiency * Patients with metabolic disorder * Patients with infectious disease * Patients with autoimmune abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T cell proportion | 1 year | We use flow cytometry to detecte peripheral blood Th1、Th2 and Treg cells of uRM and RIF patients before and after low-dose lymphocyte immunotherapy to see if the immunotherapy have treatment effect on Th1/Th2/Treg paradigm disorder |
| Abortion rate | 1 year | We undergo follow-up of all the uRM patients to see the abortion rate (miscarriage was confirmed by ultrasound before the 20th week of gestation) after lymphocyte immunotherapy |
| IVF outcomes | 1 year | We observed the the implantation rate, clinical pregnancy rate, and ongoing pregnancy rate of RIF patients after low-dose lymphocyte immunotherapy |
Countries
China
Outcome results
None listed