Poor ovarian response. Ovarian dysfunction
Conditions
Interventions
Intervention 1: Intervention group: includes 15 patients with poor ovarian response that will be treated with two injections of allogenic exosome extracted from menstrual blood stem cells. After cell
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
Female
Age
No minimum to 40 Years
Inclusion criteria
Inclusion criteria: Married woman Having previous cycles of ovarian stimulation with oocyte number of up to 3 Anti-muller hormone below 1.1 ng/ml Antral follicle below 5 Up to 40 years Sperm analysis: more than 5 million per ml; normal morphology with strict criterion of at least 1%;25% of sperm motility
Exclusion criteria
Exclusion criteria: Thyroid dysfunction Immune system disease History of cancer Hepatitis B and C and HIV Endometriosis Ovarian surgery Diabetes Liver dysfunction Kidney dysfunction Severe anemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of reactogenicity (absence of fever, nausea, bleeding, pain and allergic reaction symptoms) of allogeneic exosome injection obtained from stem cells derived from menstrual blood. Timepoint: Within two hours, two weeks, 3 months and 6 months after exosome injection. Method of measurement: Clinical assessment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous pregnancy. Timepoint: Up to 3 months after intervention. Method of measurement: Beta-HCG assay.;Number of antral follicles in the ovary. Timepoint: Before intervention, 3 months and 6 months after exosome administration. Method of measurement: Vaginal sonography.;Anti-Mullerian hormone, Estradiol, and FSH levels in blood serum. Timepoint: Before the intervention, 3 months, and 6 months after cell administration. Method of measurement: Biochemical assay.;Number and quality of oocytes in intra-cytoplasmic sperm injection cycle. Timepoint: First intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: Embryologic evaluation.;Implantation rate. Timepoint: In new intra-cytoplasmic sperm injection cycle after intervention. Method of measurement: Vaginal sonography.;Clinical pregnancy. Timepoint: 6-8 weeks after last menstrual period. Method of measurement: Vaginal sonography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAmir-Hasan Zarnani
Iranian academic center for education culture and research
Outcome results
None listed