Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss

Study Overview
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Brief Summary
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Miscarriage occurs in about 1-2% of human pregnancies and is one of the common pregnancy problems before 12 weeks of pregnancy. Anatomical and chromosomal abnormalities, microbial factors and auto and alloimmune reactions have been speculated to attribute in recurrent miscarriage. Unexplained recurrent miscarriage (URM) is defined as three or more repeated abortions, probably caused by maternal immunological rejection . Given that maternal immune system encounters semi-allogeneic fetus, pregnancy outcome is associated with the interaction between maternal immune system and immuno-regulatory capability of the fetus. Effectiveness of treatment approaches in RM patients has been controversial and remained to be discovered. Immunomodulatory agents such as corticosteroids and allogeneic lymphocyte immunization showed variable success rates in RM patients. Therapeutic effects of IVIG in unexplained RM is controversial and most positive results were obtained from the trials in RM women with cellular immune abnormalities, such as increased NK cell level and/or cytotoxicity, and T cell abnormalities. 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 at the time of positive pregnancy,400 mg/kg IVIG was administered intravenously. Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation to suppress the immune system in patients with immunological causes of RPL and the results will be compared with a control group that did not receive any type of drug.

Official Title
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Effect of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss With Immunological Causes

Conditions
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Recurrent Pregnancy Loss

Intervention / Treatment
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* Drug: IVIg


Participation Criteria
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Eligibility Criteria
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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: - Our criteria for exclusion of patients from the study include the following: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>IVIg group | Drug: IVIg<br>* Patients will take 400mg/kg IVIg at the time of positive pregnancy,Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation.<br>|
| No Intervention: control group<br>Patients who do not receive any treatment despite a history of Recurrent Pregnancy Loss problem as controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in NK cells, T reg and Th17 cells frequency. | Flowcytometry | up to 8 month of pregnancy | 
| Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21) | Elisa | up to 8 month of pregnancy | 
| Changes in exoression of cytokines gene. | RT pcr | up to 8 month of pregnancy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL) | by sonography | up to 8 month of pregnancy | 
| Live berth rate in patients with Recurrent Pregnancy Loss (RPL). | Monitoring by gynecologists | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Pregnancy Loss, IVIg, Pregnancy Rate