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AzTrials

Recurrent Implantation FailurePhase 2NCT03174964

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

A Phase 2 study testing IVIg in people with Recurrent Implantation Failure, run by Tabriz University of Medical Sciences at 1 site in Iran.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 41 years, women only
Conditions the study is for
Recurrent Implantation Failure
What is being tested?
IVIg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIran
Study dates
20 Jul 2016to 20 Sep 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 41 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Alzahra hospital

    Tabriz

Other trials in Iran

About this study

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

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.

Being tested
IVIg
Keywords
Recurrent Implantation Failure, IVIg, Pregnancy Rate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVIgDrug

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

Study groups in NCT03174964
Study groupRoleWhat they receive
Treatment groupExperimentalIVIg group
Receives: Drug: IVIg
Control groupNo interventionPatients who do not receive any treatment despite a history of Recurrent Implantation Failure problem as controls

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in NK cells, Treg AndTh17cells frequency.

    Flowcytometry

    Measured: 15 day after ET

  2. Changes in secretion levels of cytokines related to Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10)

    Elisa

    Measured: 15 day after ET

  3. Changes in secretion The amount of Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines.

    Elisa

    Measured: 15 day after ET

  4. Changes in Th17 and Treg cells(IL-17,IL-21, TGF-B and IL-10) cytokines and related transcription factor

    RT pcr

    Measured: 15 day after ET

Secondary outcomes (3)

  1. Fertility rate in patients with recurrent implantation failure (RIF)

    By sonography

    Measured: 15 day after ET

  2. Fertility rate in patients with recurrent implantation failure (RIF)

    By ELISA technique

    Measured: 15 day after ET

  3. Live berth rate in patients with recurrent implantation failure (RIF).

    Monitoring by gynecologists

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start20 Jul 2016
  3. Primary completion10 Feb 2017
  4. Study completion20 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03174964
Sponsor's protocol ID
TabrizUMS-infertility-002
Status last verified
May 2017
First submitted
28 May 2017
Last updated
17 Sep 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sugiura-Ogasawara M, Suzuki S, Ozaki Y, Katano K, Suzumori N, Kitaori T. Frequency of recurrent spontaneous abortion and its influence on further marital relationship and illness: the Okazaki Cohort Study in Japan. J Obstet Gynaecol Res. 2013 Jan;39(1):126-31. doi: 10.1111/j.1447-0756.2012.01973.x. Epub 2012 Aug 13.

    PubMed 22889462

  • Santos MA, Kuijk EW, Macklon NS. The impact of ovarian stimulation for IVF on the developing embryo. Reproduction. 2010 Jan;139(1):23-34. doi: 10.1530/REP-09-0187.

    PubMed 19710204

  • King K, Smith S, Chapman M, Sacks G. Detailed analysis of peripheral blood natural killer (NK) cells in women with recurrent miscarriage. Hum Reprod. 2010 Jan;25(1):52-8. doi: 10.1093/humrep/dep349. Epub 2009 Oct 9.

    PubMed 19819893

  • Goring SM, Levy AR, Ghement I, Kalsekar A, Eyawo O, L'Italien GJ, Kasiske B. A network meta-analysis of the efficacy of belatacept, cyclosporine and tacrolimus for immunosuppression therapy in adult renal transplant recipients. Curr Med Res Opin. 2014 Aug;30(8):1473-87. doi: 10.1185/03007995.2014.898140. Epub 2014 Apr 3.

    PubMed 24628478

  • 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.

    PubMed 12765346

  • 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.

    PubMed 17166218

  • Kolls JK, Khader SA. The role of Th17 cytokines in primary mucosal immunity. Cytokine Growth Factor Rev. 2010 Dec;21(6):443-8. doi: 10.1016/j.cytogfr.2010.11.002. Epub 2010 Nov 20.

    PubMed 21095154

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IVIg in people with Recurrent Implantation Failure, run by Tabriz University of Medical Sciences at 1 site in Iran.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in NK cells, Treg AndTh17cells frequency. (time frame: 15 day after ET). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03174964, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.

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