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Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure

Effect of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure With Immunological Causes

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03174964
Enrollment
50
Registered
2017-06-05
Start date
2016-07-20
Completion date
2017-09-20
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Implantation Failure

Keywords

Recurrent Implantation Failure, IVIg, Pregnancy Rate

Brief summary

Infertility and miscarriage ordinary events in reproductive failure in humans, as are affected one couple in every six couples of reproductive age and abortion is including in approximately 15-20% of all pregnancies. Over the decades since the beginning of Assisted Reproductive Technology (ART) and in vitro fertilization (IVF) pregnancy rate still remains below 30% and Recurrent Implantation Failure in one of the most important limiting factor is the assisted reproductive techniques. According to studies conducted in recent years one of the most important mechanisms of implantation failure is maternal immune system because the fetus as an allograft toxic (Semi allograft) to the mother. Studies have demonstrated that ratio of Th1 to Th2 cells increase in maternal peripheral blood cells can be directly associated with implantation failure. It also increases the number of natural killer (NK) cells and Th17 cells and their cytokines in peripheral blood of mother and is also associated with an increased risk of infertility. Several studies have also shown that the fertile persons in compare to infertile have increased amount of Treg cells and inhibitory cytokines associated with it. The studies have shown that if patients are properly selected RIF and placed under appropriate immunotherapy approaches it will be seen a significant increase in fertility. In previous years, followed by the production of intravenous immunoglobulin (IVIg) and determine its effect on immune suppression, IVIg uses for the treatment of various diseases such as thrombocytopenic purpura, Guillain-Barre syndrome, Kawasaki disease and Myasthenia gravis. It is also valuable drug for the treatment of patients with infertility problems have also been used but still remains how well the drug and its mechanism of action are unknown. Probably one of the mechanisms of IVIg is its effect in suppressing the activity of NK cells. Likely IVIg cause to increase Cluster of Differentiation 94 (CD94) molecule as an inhibitor molecule on the NK cells and reduced the cytotoxic activity of NK cells. So because of reduce the cytotoxic activity of NK cells by IVIg in patients with RIF injection increases the likelihood of successful implantation. 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 before IVF to suppress the immune system in patients with immunological causes of RIF and the results will be compared with a control group that did not receive any type of drug.

Interventions

DRUGIVIg

Patients will take a dose of 400mg/kg of IVIg 2 days before ET.

Sponsors

Tabriz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 41 Years
Healthy volunteers
No

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in NK cells, Treg AndTh17cells frequency.15 day after ETFlowcytometry
Changes in secretion levels of cytokines related to Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10)15 day after ETElisa
Changes in secretion The amount of Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines.15 day after ETElisa
Changes in Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines and related transcription factor15 day after ETRT pcr

Secondary

MeasureTime frameDescription
Fertility rate in patients with recurrent implantation failure (RIF)15 day after ETBy sonography
Live berth rate in patients with recurrent implantation failure (RIF).up to 1 yearMonitoring by gynecologists

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026