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Effectiveness of intrauterine injection in clinical pregnancy occurrence

Evaluation of the Effectiveness of Intrauterine Injection of Peripheral Blood Mononuclear Cells Treated with hCG on Clinical Pregnancy Outcomes in Patients with Recurrent Implantation Failure (RIF): A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160815029374N10
Enrollment
40
Registered
2025-12-08
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Infertility. Female infertility associated with anovulation

Interventions

Intervention 1: Intervention group: From these patients, 20 milliliters of peripheral blood will be drawn and placed into tubes containing the anticoagulant EDTA. After isolating PBMCs using Ficoll, t

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Minimum history of 3 previous unsuccessful IVF/ET treatments Primary infertility cases Age under 40 years BMI between 18 and 25 Regular and natural menstrual cycles for at least 3 consecutive months (each cycle lasting between 25-35 days) Failure to identify specific primary causes in the development of infertility conditions

Exclusion criteria

Exclusion criteria: Abnormal levels of thyroid hormones / FSH / LH / Estrogen / Progesterone / GH / Insulin / Glucagon Presence of anatomical problems in the uterus using ultrasound or hysteroscopy Presence of a history of genetic disease or an abnormal karyotype in the mother or father, or through cytological examinations. Presence of coagulation disorder and abnormal thrombophilia screening (V Leiden, Prothrombin, Antithrombin III) Evidence of genital infection The presence of a specific cause or related underlying factor associated with pregnancy failure Presence of a tumor or other diseases with abnormal test results

Design outcomes

Primary

MeasureTime frame
(Clinical pregnancy onset). Timepoint: Two weeks. Method of measurement: Test and ultrasound.;(Implantation rate). Timepoint: Two weeks. Method of measurement: Test and ultrasound.

Secondary

MeasureTime frame
The extent of side effects resulting from the treatment will also be evaluated based on the designed questionnaire and the specialist doctor's visit. Timepoint: two week. Method of measurement: exam - Ultrasound.;The relationship between the incidence of clinical pregnancy in patients with recurrent implantation failure (RIF) and the Th1/Th2 cell ratio will be determined. Timepoint: two week. Method of measurement: exam - Ultrasound.;The impact of endometrial thickness at the time of embryo transfer on treatment effectiveness will be evaluated in the intervention group. Timepoint: two week. Method of measurement: exam - Ultrasound.;The impact of the number of previous failures (the number of unsuccessful IVF attempts) on the effectiveness of treatment with hCG-treated PBMCs will be evaluated. Timepoint: two week. Method of measurement: exam - Ultrasound.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarzieh Zamaniyan

Mazandaran University of Medical Sciences

MarziehZamaniyan@gmail.com+98 11 3336 1700

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026