Premature ovarian failure. Primary ovarian failure
Conditions
Interventions
Intervention 1: Intervention group: In the first phase, the study will be non-randomized, and bilateral intraovarian injection of 25 million hPMSc cells will be performed in 3 eligible patients. The p
however, hormonal and ultrasound evaluations will be conducted at the baseline and 4 months after.
Sponsors
Taskin Bioregeneration
Eligibility
Sex/Gender
Female
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: Females aged 18 to 40 years who have received a confirmed diagnosis of premature ovarian failure (POF) Secondary amenorrhea (the absence of menstruation) for over 4 months, along with a raised follicle-stimulating hormone (FSH) level exceeding 25 (IU/L) in two successive tests. A signed written consent form Presence of injectable ovaries as determined by ultrasound, with the average size of each ovary being greater than 10 millimeters.
Exclusion criteria
Exclusion criteria: History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.) as well as Thyroid disease, Immune system diseases (such as lupus, etc). A background of surgical, chemotherapy, or radiotherapy treatments for cancer. Congenital anomalies of the reproductive system or the existence of ovarian tumors. Positive serological evidence regarding previous or current hepatitis B and C, Human T-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis A history of recent (within the past year) novel POF treatment interventions, including Platelet-Rich Plasma, cell therapy, or treatment utilizing mesenchymal cell-derived extracellular vesicles (EVs). Couples experiencing severe male infertility necessitating surgical sperm retrieval. The presence of a genetic basis with abnormal karyotyping and FMR1 testing, along with a family history of POF. Patients suffering from moderate to severe endometriosis (including the presence of ovarian endometriomas). A lack of willingness to comply with the follow-up program or a preference for alternative medicine treatments during the follow-up period. A history of severe drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the first phase of the study is to assess the safety of intra-ovarian injection of human placenta derived Mesenchymal Stromal Cell (Destrosol), including evaluation of both early and late adverse effects. Timepoint: First 24 hours, first week and monthly up to 4 months after injection. Method of measurement: Sonographic evaluation to assess any potential ovarian lesions, including abscesses, hematomas, or cysts, up to 4 months after intra-ovarian injection of human placental mesenchymal stromal cell-derived (DestroCell) will be recorded at follow-up visits (first 24 hours and first week after each injection, and 1, 2, 3, and 4 months after the second injection).;The primary objective in phase two of the study is to evaluate the effectiveness of the treatment, assessing the level of change in serum follicle-stimulating hormone (FSH). Timepoint: Baseline serum FSH level before injection, one week after each infusion, and also one, two, three, and four months after the second injection. Method of measurement: Blood samples will be analyzed at the specialized Royan Institute Research Laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Menstruation recurrence rate. Timepoint: One, two, three, four months after the intraovarian injection. Method of measurement: Through regular monthly follow-ups and consultations with a physician.;Assessment of ovarian volume. Timepoint: Initial check before injection and monthly checks up to four months after the after the intraovarian injection. Method of measurement: Through a Doppler vaginal ultrasound examination performed by a collaborating radiologist in the project.;Serum levels of luteinizing hormone (LH) and estradiol. Timepoint: Assessing baseline serum levels of luteinizing hormone (LH) and estradiol before injection, one week after each injection, and also one, two, three, and four months after the injection. Method of measurement: Blood samples will be analyzed at the specialized Royan Institute Research Laboratory.;Serum anti-Müllerian hormone level assessment. Timepoint: Monitoring basal serum anti-Müllerian hormone (AMH) levels before injection, two and four months after the injection. Method of measurement: Blood samples will be analyzed at the specialized Royan Institute Research Laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHoda Madani
Royan Institute
Outcome results
None listed