CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Peripheral Blood Monouclear Cell +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03267797
NCT03267797N/ACompleted

Intrauterine Administration of Autologous hCG-activated Peripheral Blood Mononuclear Cells Improves Pregnancy Outcomes in Patients With Recurrent Implantation Failure; a Double-blind Randomized Control Trial Study

SCARM Institute, Tabriz, Iran·interventional·Posted Aug 30, 2017·Updated Aug 26, 2019

In Brief

A clinical study evaluating Peripheral Blood Monouclear Cell and Phosphate Baffer Saline for Recurrent Implantation Failure. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Despite the many research done in the field of infertility and in vitro fertilization (IVF), more than half of the embryos transmitted in the IVF and intracytoplasmic sperm injection (ICSI) do not implant successfully. Currently, pregnancy failure following at least three IVF/ET cycle, so that one or two high-quality embryos transmitted in each cycle is defined as recurrent implantation failure (RIF). Maternal and fetal factors can be a reason for implantation failure; maternal factors include endometrial receptivity, uterine anatomic abnormalities, and immunologic factors. Implantation failure with embryonic reasons includes genetic abnormalities and any factor that affects the implantation and growth of the embryo within the uterus. In recent years, the involvement of immune-related factors mainly natural killer cells (NK), dendritic cells (DCs), macrophages (MQ), regulatory T cells (Treg) and Th-1, in the endometrial differentiation and development and endometrial receptivity, as well as induction of immunological tolerance to the fetus, have been reported.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIran
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 30, 2017
Enrollment StartOct 7, 2017
Primary CompletionSep 25, 2018
Study CompletionJul 11, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.8 years ago

Interventions

Peripheral Blood Monouclear Cellother

Blood samples (20 mL) were taken from individual patients at the time of ovulation induction. Then PBMC were isolated and cultured (20-30 million cells) 48 hour at the presence of hCG (10IU/ml daily). Afterward,15-20 million PBMCs in 500 microlitres PBS were injected into the uterine cavity two days before embryo transfer (ET) using ET catheter.

Phosphate Baffer Salineother

Only 500 microlitres PBS will be injected into the uterine cavity, instead of PBMCs, two days before embryo transfer (ET) using ET catheter.