Clinical trial NCT03081325: A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy
Official title: A Preliminary Study About Unexplained Recurrent Miscarriage and Repeated Implantation Failure Patients Treated With Low-dose Lymphocyte Immunotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Unexplained Recurrent Miscarriage and Recurrent Implantation Failure
Keywords: uRM
RIF
Th1
Th2
Treg
lymphocyte immunotherapy
Lead sponsor: Nanjing University
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 292
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: T cell proportion
timeFrame: 1 year
measure: Abortion rate
timeFrame: 1 year
measure: IVF outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Reproductive Medicine Center, The Affiliated Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
Study officials:
References:
citation: Liu M, Zhen X, Song H, Chen J, Sun X, Li X, Zhou J, Yan G, Ding L, Sun H. Low-dose lymphocyte immunotherapy rebalances the peripheral blood Th1/Th2/Treg paradigm in patients with unexplained recurrent miscarriage. Reprod Biol Endocrinol. 2017 Dec 16;15(1):95. doi: 10.1186/s12958-017-0315-9.