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Evaluation of pregnancy outcomes in women with low immune profile of endometrium in recurrent implantation failure after intrauterine receiving peripheral blood mononuclear cells (PBMC)

Evaluation of pregnancy outcomes in women with low immune profile of endometrium in recurrent implantation failure after intrauterine receiving peripheral blood mononuclear cells (PBMC): clinical trial, phase II

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160422027520N29
Enrollment
100
Registered
2026-05-11
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

The studied disease is repeated implantation failure(RIF).

Interventions

Intervention group: People receiving peripheral blood mononuclear cells.

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1- All samples are from mothers aged 30-40 years. 2- All blood donors have no history of uterine problems (endometriosis, septate uterus), no ovarian problems (polycystic ovaries, weak ovarian reserve), no chromosomal abnormalities, no autoantibodies such as anti-TPO, anti-TG, ANA, APA, ACA, and anti-dsDNA. 3- BMI of people under 30 4- They are free of any uterine pathology. 5- The Siemens analysis and DNA fragmentation test of their spouses are normal.

Exclusion criteria

Exclusion criteria: 1- People aged less than 30 years or older than 40 years 2- Having ovarian problems (polycystic ovaries) 3- Presence of any uterine pathology (endometriosis, septate uterus) 4- Poor ovarian reserve (FSH>15 mIU/ml) 5- Having chromosomal abnormalities 6- Presence of autoantibodies such as anti-TPO, anti-TG, ANA, APA, ACA and anti-dsDNA. 7- The presence of mutations involving the coagulation system, such as factor XII, Pro C, Pro S8 deficiency - patients whose HIV, HCV or HBV test results are positive.

Design outcomes

Primary

MeasureTime frame
Counting of Th1 and Th2 in RIF patients - Counting of B cells in RIF patients - Counting of NK cells in RIF patients - Examination of autoantibodies panel Evaluation of pregnancy rate in patients with recurrent implantation failure Evaluation of live birth rate in RIF patient group Evaluation of abortion rate in women with RIF with low endometrial immune profile conditions. Timepoint: At the beginning of the study, counting of T and B lymphocytes as well as NK cells is done to identify people with low endometrial immunity, and in the next step, peripheral blood mononuclear cells are prescribed, and after 9 months, the rate of live births and abortions, as well as the pregnancy rate between the two intervention and control groups, are measured. Method of measurement: The method of counting lymphocytes and NK cells is with the help of flow cytometry, and the absence of autoantibodies is done with the help of ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Yousefi

Tabriz University of Medical Sciences

Yousefime@tbzmed.ac.ir084133355921

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026