Condition 1: unexplained infertility (RIF/RPL). Condition 2: RIF/RPL. Female infertility, unspecified Female infertility of other origin
Conditions
Interventions
Intervention gInjection of 106/kg dose of local Treg cells inside the uterine cavity to patients who are qualified to participate in the studyroup:.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to 42 Years
Inclusion criteria
Inclusion criteria: Definitive diagnosis of infertility, recurrent abortion or recurrent implantation failure based on clinical evaluation tests that exclude other causes of infertility. Women with abnormal Th1/Th2, Th17/Treg ratio - The normality of the menstrual cycle (24-35 days) The normality of the hormonal profile, including: FSH, LH, estradiol E2, prolactin on day 2-3 of the menstrual cycle Normality of ovarian function by checking inhibin B levels, AMH hormones Normality of the uterine anatomy Normality of the thyroid gland by measuring the TSH level Body mass index less than or equal to 25 (BMI =25) Normal karyotype The chlamydia infection test is negative No infection of the reproductive system and other parts of the body Immunization level of anti-rubella antibody or carry out immunization to achieve immunization level - The normality of the sperm test in the male sexual partner Normality of testosterone hormone test in male sexual partner Completion of the consent form based on the new human treatment method
Exclusion criteria
Exclusion criteria: History or evidence of malignant disease of the reproductive system in the last 3 years Substance abuse and smoking in either couple Current or recent use (within two to four weeks prior to treatment) of oral or systemic corticosteroids, hormone therapy (estrogen, progesterone, contraceptives), danazol, anticoagulants, herbal supplements or herbs with potential hormonal effects Use of drugs targeting T cells or interleukin-2 (e.g. alemtuzumab, basiliximab, daniloquine diphtitox) within the last 100 days Diabetes type 1 or 2 anemia (Hb 2-fold normal, total bilin > 2.5 mg/dl) Cardiovascular disease kidney disease (BUN > 30 mg/dl, Cr > 1.6 mg/dl)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients who show adverse effects during or after Regulatory T Cell injection. Timepoint: From the first dose of Treg cells injection until 12 months after the injection as 3 month intervals. Method of measurement: Patient medical examinations in patient visits to infertility clinic for follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Response to treatment: Pregnancy success naturally or IVF in studied infertile women (based on clinical and laboratory tests). Timepoint: From the first dose of Treg cells injection until 12 months after the injection as 3 month intervals. Method of measurement: Patient medical examinations in patient visits to infertility clinic for follow-up. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Mehravar
Shahid Beheshti University of Medical Sciences
Outcome results
None listed