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Completed

NCT Number: NCT03174951

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

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.

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Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Alzahra hospital

Tabriz, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IVIG

Drug

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.

Primary outcomes

  1. Changes in NK cells, T reg and Th17 cells frequency.

    Time frame: up to 8 month of pregnancy

    Flowcytometry

  2. Changes in secretion levels of cytokines related to Treg and Th17 cells(IL-17,IL-21)

    Time frame: up to 8 month of pregnancy

    Elisa

  3. Changes in exoression of cytokines gene.

    Time frame: up to 8 month of pregnancy

    RT pcr

Secondary outcomes

  1. Ongoing pregnancy rate in patients with Recurrent Pregnancy Loss (RPL)

    Time frame: up to 8 month of pregnancy

    by sonography

  2. Live berth rate in patients with Recurrent Pregnancy Loss (RPL).

    Time frame: up to 1 year

    Monitoring by gynecologists

Sponsors and collaborators

Lead sponsor

Tabriz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 5, 2017
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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