Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss
Status:
Completed
Trial end date:
2017-06-20
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
SCARM Institute, Tabriz, Iran Tabriz University of Medical Sciences