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

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ClinicalTrials.gov Identifier: NCT03081325
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Li-jun Ding, 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.

Condition or disease Intervention/treatment Phase
Unexplained Recurrent Miscarriage and Recurrent Implantation Failure Procedure: low-dose lymphocyte immunotherapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 292 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy
Study Start Date : March 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage

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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081325


Locations
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China, Jiangsu
Reproductive Medicine Center, The Affiliated Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Sponsors and Collaborators
Nanjing University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Li-jun Ding, Principal Investigator, Nanjing University
ClinicalTrials.gov Identifier: NCT03081325     History of Changes
Other Study ID Numbers: BL2015007
First Posted: March 16, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018

Keywords provided by Li-jun Ding, Nanjing University:
uRM
RIF
Th1
Th2
Treg
lymphocyte immunotherapy

Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Habitual
Pregnancy Complications
Immunologic Factors
Physiological Effects of Drugs