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

Tabriz University of Medical Sciences

Status and phase

Completed

Phase 2

Conditions

Recurrent Pregnancy Loss

Treatments

Drug: IVIg

Study type

Interventional

Funder types

Other

Identifiers

NCT03174951

TabrizUMS-infertility-003

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

No Healthy Volunteers

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.