Ignite Creation Date:
2024-05-06 @ 10:06 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03161340
Status:
COMPLETED
Last Update Posted:
2019-04-10
First Post:
2017-05-18
Brief Title:
Immunomodulatory Effects of Rapamycin on Pregnancy Rate of Patient With Recurrent Implantation Failure
Sponsor:
Mehdi Yousefi
Organization:
Tabriz University of Medical Sciences
Study Overview
Official Title:
Effect of Rapamycin on Pregnancy Rate of Patient With Recurrent Implantation Failure With Immunological Causes
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Repeated implantation failure RIF is determined as failure to achieve pregnancy following at least 3 embryo transfers of high quality embryos in IVF cycles Successful implantation and pregnancy depend on the activity of a variety of factors such as adhesion molecules cytokines and immune cellsThe process by which the foreign conceptus is accepted requires the appropriate function of regulatory T cells Treg which are known as the mediators of immune regulation Tregs are capable of inducing maternal tolerance toward the fetus and their systemic expansion has been observed in early pregnancy Furthermore Th17 cells that play important roles in mounting inflammation are involved in the maintenance of pregnancy as a subset of effector T cellsThe mammalian target of rapamycin mTOR inhibitors are immunosuppressive agents used after solid organ transplantation Sirolimus as the most common mTOR inhibitor is able to effectively prevent allograft rejection and possesses significant antitumor properties Pregnancy is a state of immunosuppression and the dysregulated immune responses has been observed in women with RIF Accordingly modulation of the immune system by an immunosuppressant drug may present an approach to overcome implantation failure In this context the use of Sirolimus might offer promise to achieve a better pregnancy outcome among women with implantation failure who undergo IVF Based on previous findings we hypothesized that Sirolimus may be beneficial for the improvement of pregnancy rate in women with IVF failure
In the current study we performe randomized phase II clinical trial to determine whether Sirolimus could be used as a bona fide treatment to increase the success rate of IVF in women with RIF of immune etiologiesA total 121 patients with a history of at least 3 RIF after IVFET cycles that will refer to Eastern Azerbaijan ACECR ART center Alzahra Hospital of Tabriz University of Medical Sciences and Infertility Treatment center ACER Qom from July 2017 to June 2018 were select and enroll in this multicenter randomized double-blind phase II study
Normal ranges for Th17Treg cell ratios establish using 50 normal fertile women who had a history of normal delivery by natural conception
In patients with elevated Th17Treg ratios half of them treat with Sirolimus Rapamune Pfizer UK and rest of patients not treat control group The patients in the treatment group will began Sirolimus 2 days prior to embryo transfer ET and will continue until the day of pregnancy test 15 day after ET for a total of 17 days Sirolimus administe in a daily dose of 2mg
In the current study we performe randomized phase II clinical trial to determine whether Sirolimus could be used as a bona fide treatment to increase the success rate of IVF in women with RIF of immune etiologiesA total 121 patients with a history of at least 3 RIF after IVFET cycles that will refer to Eastern Azerbaijan ACECR ART center Alzahra Hospital of Tabriz University of Medical Sciences and Infertility Treatment center ACER Qom from July 2017 to June 2018 were select and enroll in this multicenter randomized double-blind phase II study
Normal ranges for Th17Treg cell ratios establish using 50 normal fertile women who had a history of normal delivery by natural conception
In patients with elevated Th17Treg ratios half of them treat with Sirolimus Rapamune Pfizer UK and rest of patients not treat control group The patients in the treatment group will began Sirolimus 2 days prior to embryo transfer ET and will continue until the day of pregnancy test 15 day after ET for a total of 17 days Sirolimus administe in a daily dose of 2mg
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None