Primary ovarian failure. Primary ovarian failure
Conditions
Interventions
Intervention group: Two intratubal injections of allogeneic umbilical cord-derived mesenchymal stromal cells are performed in 15 patients with Primary Ovarian Insufficiency (POI). The injection of 5×1
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Have established regular menstrual cycle, oligomenorrhea / amenorrhea = 4 months FSH (Follicle-Stimulating Hormone) > 25 IU/mL ????????? ????? XX46 The duration of amenorrhea is less than 3 years The average diameter of the ovary is above 10 mm
Exclusion criteria
Exclusion criteria: Primary amenorrhea Thyroid dysfunction, TSH > 0.4 L/mIU Serious systemic diseases, cardiovascular, liver, kidney, blood system and all uncontrolled chronic diseases (diabetes, …) Pregnancy contraindications History of PID, endometriosis, ovarian cyst surgery, uterine myoma History of cancer, chemotherapy, radiation therapy Congenital abnormalities of the reproductive system Autoimmune diseases such as MS, SLE Spouse with sperm count less than 10 ml/m, and normal sperm shape less than 4% Smoking Positive viral tests for HCV, HBS, HIV,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of side effects, including short-term and long-term, systemic or local side effects and severe or mild side effects. Timepoint: first 24 hours, 1st and 2nd week, 1st, 2nd, 3rd, 4th, 5th, 6th month after injection. Method of measurement: clinical examinations and laboratory tests. | — |
Secondary
| Measure | Time frame |
|---|---|
| Correction of hormonal status such as reduction of FSH level. Timepoint: First 24 hours, week 1 and 2, month 1, 2, 3, 4, 5, 6 after injection. Method of measurement: laboratory tests. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir Bajouri
Tehran University of Medical Sciences
Outcome results
None listed