Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure

September 13, 2018 updated by: Tabriz University of Medical Sciences

Effect of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure With Immunological Causes

Infertility and miscarriage ordinary events in reproductive failure in humans, as are affected one couple in every six couples of reproductive age and abortion is including in approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains below 30% and Recurrent Implantation Failure in one of the most important limiting factor is the assisted reproductive techniques. According to studies conducted in recent years one of the most important mechanisms of implantation failure is maternal immune system because the fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly associated with implantation failure. It also increases the number of natural killer (NK) cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated with an increased risk of infertility. Several studies have also shown that the fertile persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines associated with it. The studies have shown that if patients are properly selected RIF and placed under appropriate immunotherapy approaches it will be seen a significant increase in fertility. In previous years, followed by the production of intravenous immunoglobulin (IVIg) and determine its effect on immune suppression, IVIg uses for the treatment of various diseases such as thrombocytopenic purpura, Guillain-Barre syndrome, Kawasaki disease and Myasthenia gravis. It is also valuable drug for the treatment of patients with infertility problems have also been used but still remains how well the drug and its mechanism of action are unknown. Probably one of the mechanisms of IVIg is its effect in suppressing the activity of NK cells. Likely IVIg cause to increase Cluster of Differentiation 94 (CD94) molecule as an inhibitor molecule on the NK cells and reduced the cytotoxic activity of NK cells. So because of reduce the cytotoxic activity of NK cells by IVIg in patients with RIF injection increases the likelihood of successful implantation. Previous studies have shown that the incidence of genetic abnormalities in children who have received immunosuppressive drugs such as IVIg like normal people and normal society. In this study we used IVIg before IVF to suppress the immune system in patients with immunological causes of RIF and the results will be compared with a control group that did not receive any type of drug.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

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

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 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Enrolled patients will experience at least 3 times recurrent pregnancy loss.
  • Patients dont have history of any type of immunotherapy.
  • Patients must have abnormal NK cell or NK cell cytotoxicity or Th1/Th2 ratio

Exclusion Criteria:

  • Patients or their spouse has abnormal karyotype or chromosomal and genetically disorders.
  • Patients who have bleeding problems.
  • Patients who have chronic disorders those are forced to use the specific drug.
  • Patients who have positive test for HIV, HCV or HBV infection.
  • Patients who have a history of asthma and allergies.
  • Patients who have uterus 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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
IVIg group
Drug: IVIg
Patients will take a dose of 400mg/kg of IVIg 2 days before ET.
No Intervention: Control group
Patients who do not receive any treatment despite a history of Recurrent Implantation Failure problem as controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in NK cells, Treg AndTh17cells frequency.
Time Frame: 15 day after ET
Flowcytometry
15 day after ET
Changes in secretion levels of cytokines related to Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10)
Time Frame: 15 day after ET
Elisa
15 day after ET
Changes in secretion The amount of Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines.
Time Frame: 15 day after ET
Elisa
15 day after ET
Changes in Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines and related transcription factor
Time Frame: 15 day after ET
RT pcr
15 day after ET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertility rate in patients with recurrent implantation failure (RIF)
Time Frame: 15 day after ET
By sonography
15 day after ET
Fertility rate in patients with recurrent implantation failure (RIF)
Time Frame: 15 day after ET
By ELISA technique
15 day after ET
Live berth rate in patients with recurrent implantation failure (RIF).
Time Frame: up to 1 year
Monitoring by gynecologists
up to 1 year

Collaborators and Investigators

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

Sponsor

Tabriz University of Medical Sciences

Investigators

  • Study Director: Mehdi Yousefi, Immunologist, SCARM Institute

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 (Actual)

July 20, 2016

Primary Completion (Actual)

February 10, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

May 28, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (Actual)

June 5, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TabrizUMS-infertility-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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