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The Effect of Tacrolimus in patients with recurrent implantation failure

Investigation of gene expression and secretion of P53, LIF, IL_10, IL-17 after administration of tacrolimus in endometrial and uterine fluid in patients with repeated implantation failure: Clinical trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20171007036623N1
Enrollment
10
Registered
2017-11-29
Start date
2017-12-11
Completion date
Unknown
Last updated
2018-02-22

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 of uterin

Interventions

Intervention 1: Prescription of Tacrolimus in the second menstrual cycle for up to 16 days (until 2 days before second biopsy) with 1-3 mg per day upon on IFN-g/IL-4 ratio: Prescription of 1 mg per d
Treatment - Drugs
Prescription of Tacrolimus in the second menstrual cycle for up to 16 days (until 2 days before second biopsy) with 1-3 mg per day upon on IFN-g/IL-4 ratio: Prescription of 1 mg per day if this rati
Prescription of Tacrolimus in third cycle of menstruation from 2 days before embryo transfer until 14 days after embryo transfer for overall 16 days with 1-3 mg per day upon on IFN-g/IL-4 ratio. Pr

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: History of 3 or more failed IVF/ET cycles with morphologically and developmentally average to good-quality embryo( 7 or more blastomeres and less than 10% fragmentation in day 3 ) into an adequately prepared endometrium (endometrial thickness equal or more than 8 mm); Women who had regular menses (25 to 35 days); Women who had normal karyotype; women who had at least one of these Immunological disorders in their peripheral blood sample between day of 5 to 10 of menstrual cycle: IFN-g/IL-4 equal or more than 10.3 or Nk-cell percentage greater than 12%

Exclusion criteria

Exclusion criteria: Present of sub mucosal fibroids, endometrial polyps, intrauterine adhesions, congenital anomalies of uterus or hydrosalpinges History of active autoimmune disease (With assessment of ANA, Anti-TG, Anti-TPO, Anti-dsDNA); Women with acquired or inherited thrombophilia (With assessment of Factor2, Factor5, Factor 8, Fibrinogen, Anti- Cardiolipin, Anti-Phospholipid Antibody, Lupus Anti-Coagulate, s-MTHFR gene) Pregnant women; History of miscarriage in a former IVF/ET cycle; Women who received vaccine in the last three months; Women who received steroid hormones in the last 2 months; Women receiving immunotherapy; Women with chronic inflammatory diseases

Design outcomes

Primary

MeasureTime frame
Expression of P53 gene. Timepoint: Measure twice: before and after treatment. Method of measurement: qRT-PCR.;Expression of LIF gene. Timepoint: Measure twice: before and after treatment. Method of measurement: qRT-PCR.;Expression of IL-10 gene. Timepoint: Measure Twice: before and after treatment. Method of measurement: qRT-PCR.;Expression of IL-17 gene. Timepoint: Measure twice: before and after treatment. Method of measurement: qRT-PCR.

Secondary

MeasureTime frame
LIF protein levels in uterine fluid. Timepoint: Measure twice: before and after treatment. Method of measurement: ELISA.;Level Of IL-10 protein in uterine fluid. Timepoint: Measure twice: before and after treatment. Method of measurement: ELISA.;Level Of IL-17 protein in uterine fluid. Timepoint: Measure twice: before and after treatment. Method of measurement: ELISA.;Biochemical Pregnancy Rate. Timepoint: Two weeks after embryo transfer. Method of measurement: Level of B-HCG in blood.;Live Birth Rate. Timepoint: Nine months after embryo transfer. Method of measurement: Number of newborns.;Embryo implantation Rate. Timepoint: Two weeks after a chemical pregnancy confirmation. Method of measurement: Observation of Pregnancy Sac by Ultrasound.;Blood level of Estradiol. Timepoint: Measure twice: before and after treatment. Method of measurement: Measurement in blood.;Blood level of Progestron. Timepoint: Measure twice: before and after treatment. Method of measurement: Measurement in blood.;P53 protein level in endometrium. Timepoint: Measure twice: before and after treatment. Method of measurement: immunohistochemistry.;LIF protein level in endometrium. Timepoint: Measure twice: before and after treatment. Method of measurement: immunohistochemistry.;IL-10 protein level in endometrium. Timepoint: Measure twice: before and after treatment. Method of measurement: immunohistochemistry.;IL-17 protein level in endometrium. Timepoint: Measure twice: before and after treatment. Method of measurement: immunohistochemistry.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Bahrami Asl

Shahid Beheshti University of Medical Sciences

za.bahrami@sbmu.ac.ir+98 23872555

Outcome results

None listed

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