A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy

Phase 1

Completed

• Conditions: Unexplained Recurrent Miscarriage and Recurrent Implantation Failure

• Registration Number: NCT03081325
• Lead Sponsor: Nanjing University

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-10
• Study First Posted: 2017-03-16
• Primary Completion: 2017-06
• Study Completion: 2017-07-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 292

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Reproductive Medicine Center, The Affiliated Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China