NCT03174951

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

Completed Phase 2 Last updated 17 September 2018

What this trial tests

Phase 2 trial testing IVIg in Recurrent Pregnancy Loss in 50 participants. Completed in 20 June 2017.

Timeline

20 September 2016

Primary endpoint
10 March 2017

20 June 2017

Quick facts

Lead sponsor	Tabriz University of Medical Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	20 September 2016
Primary completion	10 March 2017
Estimated completion	20 June 2017
Sites	1 location across Iran

Drugs / interventions tested

• IVIg — full drug profile →

Conditions studied

• Recurrent Pregnancy Loss — all drugs for Recurrent Pregnancy Loss →

Sponsor

Tabriz University of Medical Sciences

Who can join

Adults 18 to 41, female only, with Recurrent Pregnancy Loss. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dual Role of Natural Killer Cells in Early Pregnancy: Immunopathological Implications and Therapeutic Potential in Recurrent Spontaneous Abortion and Recurrent Implantation Failure.
   Guan D, Chen Z, Zhang Y, Sun W, et al · · 2025 · cited 7× · PMID 40325291 · DOI 10.1111/cpr.70037