Premature menopause (POF)/premature ovarian insufficiency (POI). Female infertility associated with anovulation
Conditions
Interventions
Intervention 1: Intervention group: Intraovarian injection of exosomes with a puncture needle under ultrasound guidance. POF patients who did not receive exosomes. Intervention 2: Control group: POF p
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
Female
Age
25 Years to 40 Years
Inclusion criteria
Inclusion criteria: Serum AMH less than 0.3 ng/mL at screening visit and in the absence of OC or sex steroid use Antral follicle count (AFC) less than 4 in both ovaries (at screening visit and in the absence of OC or sex steroid use) Normal thyroid hormones (TSH) and (FT4) Normal prolactin levels Normal fasting blood sugar level Negative history of endometrioma or other ovarian cysts, negative history of ovarian surgery, negative history of cancer, negative history of a known autoimmune disorder
Exclusion criteria
Exclusion criteria: Patients with abnormal thyroid function Patients with genetic problems (including Turner syndrome, fragile X syndrome) Patients with Cushing's syndrome • Patients infected with HIV, HBV, HCV People being treated with other medicinal products that may affect stem cell function Those with heart, lung, liver, kidney, blood, autoimmune, behavioral, or other clinically significant diseases, including malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improving symptoms of uterine masses. Timepoint: A period. Method of measurement: Ultrasound.;Evaluation of reactogenicity (absence of fever, nausea, bleeding, pain, and signs of allergic reaction) of exosome injection at different time points. Timepoint: Before the intervention, two hours, two weeks, 3 months, and 6 months after exosome injection. Method of measurement: Clinical evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in menstrual periods (resumption, regularity). Timepoint: Before the start of the intervention and 2, 4, 6 months after the intervention. Method of measurement: Consulting.;Serum levels of anti-Müllerian hormone, estradiol, and FSH. Timepoint: Before the start of the study, 3, and 6 months after exosome injection. Method of measurement: Biochemistry measurement.;Serum levels of anti-Müllerian hormone, estradiol, and FSH. Timepoint: Before the start of the study, 3, and 6 months after injection. Method of measurement: Biochemistry measurement.;Number of antral follicles in the ovary. Timepoint: Before the start of the study and 3, 6 months after exosome injection. Method of measurement: Vaginal ultrasound.;Spontaneous pregnancy. Timepoint: Within 3 months after the start of the intervention. Method of measurement: Beta-hCG measurement.;Number and quality of eggs obtained in an intracytoplasmic sperm injection treatment cycle. Timepoint: The first cycle of intracytoplasmic sperm injection treatment after the intervention. Method of measurement: Embryological evaluation.;Embryo implantation rate. Timepoint: In the new cycle of intracytoplasmic sperm injection after the intervention. Method of measurement: Vaginal ultrasound.;Pregnancy. Timepoint: 6 - 8 weeks after the first day of your last period. Method of measurement: Vaginal ultrasound. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAtefeh Verdi
Iranian academic center for education culture and research
Outcome results
None listed