Clinical trial NCT03174951: Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss
Official title: Effect of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss With Immunological Causes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Pregnancy Loss
Keywords: Recurrent Pregnancy Loss
IVIg
Pregnancy Rate
Lead sponsor: Tabriz University of Medical Sciences
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in NK cells, T reg and Th17 cells frequency.
timeFrame: up to 8 month of pregnancy
measure: Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21)
timeFrame: up to 8 month of pregnancy
measure: Changes in exoression of cytokines gene.
timeFrame: up to 8 month of pregnancy
Secondary outcomes:
measure: Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL)
timeFrame: up to 8 month of pregnancy
measure: Live berth rate in patients with Recurrent Pregnancy Loss (RPL).
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Alzahra hospital
Study officials:
affiliation: Head of SCARM institute
name: Mohammad Nouri, Ph.D
role: STUDY_CHAIR
affiliation: SCARM institute
name: Mehdi Yousefi, Immunologist
role: STUDY_DIRECTOR
References:
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citation: Yamada H, Morikawa M, Furuta I, Kato EH, Shimada S, Iwabuchi K, Minakami H. Intravenous immunoglobulin treatment in women with recurrent abortions: increased cytokine levels and reduced Th1/Th2 lymphocyte ratio in peripheral blood. Am J Reprod Immunol. 2003 Feb;49(2):84-9. doi: 10.1034/j.1600-0897.2003.01184.x.
citation: Hutton B, Sharma R, Fergusson D, Tinmouth A, Hebert P, Jamieson J, Walker M. Use of intravenous immunoglobulin for treatment of recurrent miscarriage: a systematic review. BJOG. 2007 Feb;114(2):134-42. doi: 10.1111/j.1471-0528.2006.01201.x. Epub 2006 Dec 12.
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