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Tacrolimus in clinical pregnancy onset of repeated implantation failure (RIF) patients with elevated T-cell helper1/T-cell helper2 (Th1/Th2) ratio

Efficacy and safety of tacrolimus in clinical pregnancy onset of repeated implantation failure (RIF) patients with elevated T-cell helper1/T-cell helper2 (Th1/Th2) ratio: a randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231127060207N1
Enrollment
80
Registered
2024-07-10
Start date
2024-05-21
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

repeated implantation failure (RIF) patients. Complications of attempted introduction of fertilized ovum following in vitro fertilization

Interventions

Intervention 1: Intervention group: Group A will include 40 patients who will receive tacrolimus at a dose of 3 mg/daily. The initiation of tacrolimus in this group will begin two days before the tran

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
No minimum to 39 Years

Inclusion criteria

Inclusion criteria: The patient should be = 39 years old. The patient should have = 3 failures in the IVF. Th1/Th2 cell ratio should be greater than or equal to 10.3.

Exclusion criteria

Exclusion criteria: Patients with abnormal karyotypes, uterine abnormalities or defects, infections, endocrine diseases, and coagulation abnormalities or thrombosis.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy onset. Timepoint: 14 days after the transfer of the embryo to the uterus. Method of measurement: Positive result of B-hcg test for patients.

Secondary

MeasureTime frame
Evaluation of changes in T-cell helper1/T-cell helper2 (Th1/Th2) ratio between groups. Timepoint: 14 days after the transfer of the embryo to the uterus. Method of measurement: Flow cytometry technique.;Measuring the expression of interleukin-10 (IL-10) between groups. Timepoint: 14 days after the transfer of the embryo to the uterus. Method of measurement: Real-time PCR.;Measuring the expression of interleukin-17 (IL-17) between groups. Timepoint: 14 days after the transfer of the embryo to the uterus. Method of measurement: Real-time PCR.

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