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Evaluation of the effectiveness of intrauterine injection of hCG-treated peripheral blood mononuclear cells on clinical pregnancy

Evaluation of the effectiveness of intrauterine injection of hCG-treated peripheral blood mononuclear cells on clinical pregnancy in patients with recurrent implantation failure (RIF): a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250701066326N1
Enrollment
80
Registered
2025-08-26
Start date
2025-09-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

recurrent implantation failure. Female infertility, unspecified

Interventions

Intervention 1: Intervention Group: Group A will consist of 40 patients with recurrent implantation failure (RIF). From these patients, 20 milliliters of peripheral blood will be collected and placed

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: At least 3 previous unsuccessful IVF/ET treatments Age under 40 years BMI between 18 and 25 Regular and normal menstrual cycles for at least 3 consecutive months (cycle length between 25-35 days) No identified primary causes of infertility

Exclusion criteria

Exclusion criteria: Abnormal levels of thyroid hormones, FSH, LH, Estrogen, Progesterone, GH, Insulin, or Glucagon Positive antiphospholipid syndrome screening test Anatomical uterine abnormalities detected by ultrasound or hysteroscopy History of genetic disease or abnormal karyotype in the mother or father, or through cytological examinations Coagulation disorders or abnormal thrombophilia screening (Factor V Leiden, Prothrombin, Antithrombin III) Evidence of genital infection Identified underlying cause related to unsuccessful pregnancy Presence of tumors or other diseases with abnormal test results

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy onset. Timepoint: 14 Days after Intervention. Method of measurement: lab test Bhcg.

Secondary

MeasureTime frame
The rate of treatment-related side effects, assessed through a designed questionnaire and specialist physician visits. Timepoint: days after intervention. Method of measurement: Investigator assessment.;The relationship between the occurrence of clinical pregnancy in patients with recurrent implantation failure (RIF) and the Th1/Th2 cell ratio. Timepoint: 14 days after intervention. Method of measurement: lab test.;The impact of endometrial thickness at the time of embryo transfer on treatment efficacy in the intervention group. Timepoint: 14 days after intervention. Method of measurement: Sonography.;The effect of the number of previous failed IVF attempts on the efficacy of treatment with hCG-treated PBMCs. Timepoint: 14 days after intervention. Method of measurement: analysis of data.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSaeid Taghiloo

Mazandaran University of Medical Sciences

saeid.taghiloo@yahoo.com+98 912 843 7681

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026