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

April 9, 2018 updated by: Li-jun Ding, Nanjing University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

292

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Reproductive Medicine Center, The Affiliated Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lymphocyte immunotherapy on uRM and RIF
Donor (husband or third party) lymphocytes were prepared by Ficoll-Paque centrifugation; the cells were washed with sterile saline and resuspended in 1 ml at a concentration of 20-40 × 106 cells/ml. The cells were given to the female partner by 4-6 intradermal injected. In this study, the lymphocyte immunization therapies were performed every 3 weeks for 3 times. After that we test Th1/Th2/Treg, if they become normal, the patients can prepare for pregnancy.
Procedure: low-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
T cell proportion
Time Frame: 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
1 year
Abortion rate
Time Frame: 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
1 year
IVF outcomes
Time Frame: 1 year
We observed the the implantation rate, clinical pregnancy rate, and ongoing pregnancy rate of RIF patients after low-dose lymphocyte immunotherapy
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 10, 2017

First Posted (Actual)

March 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BL2015007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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