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IRCT20250609066140N1 IRCT 2025-07-13 Alborz University of Medical Sciences Comparison of Pregnancy Outcomes in Patients with Poor Ovarian Response after Platelet-Rich Plasma (PRP)and Stem Cells Injection; a randomized clinical trial Comparison of Pregnancy Outcomes in Patients with Poor Ovarian Response after Platelet-Rich Plasma (PRP) and Stem Cells Injection; a randomized clinical trial 2025-08-23 anticipated 105 Complete https://irct.ir/trial/84468 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized clinical trial, block randomization is used to allocate patients into two intervention groups (PRP or stem cell therapy) and a control group. The process is as follows: 1. Homogeneous blocks (e.g., based on age or disease severity) are created. 2. Within each block, allocation sequences (e.g., AABB, ABAB) are randomly predetermined. 3. Each new patient in the block is assigned according to the pre-randomized sequence. This method ensures group balance throughout the study and within each block, Blinding description: The patients' codes and their medication types were computerized and randomly assigned, with each patient receiving a unique envelope code registered in the system. Then, the opaque, numbered envelopes were given to a third party and, after obtaining informed consent, were delivered to the therapist. The study will be conducted in a double-blind manner, meaning neither the patients, the therapist, nor the researchers will be aware of the group assignments. 2-3 Infertility. Intervention 1: First Intervention Group: Platelet-Rich Plasma (PRP) Recipient GroupThe preparation of PRP (platelet-rich plasma) will involve plasma separation via centrifugation. Approximately 20 mL of blood will be drawn under sterile conditions, and PRP will be prepared using an autologous platelet-rich plasma kit according to the manufacturer's protocol.In summary, after blood collection, the tubes will be centrifuged at 830 × *g* for 8 minutes. A 16-gauge needle attached to a 5-mL syringe will then be inserted into the tube, advancing just above the buffy coat layer. The PRP will be collected by rotating the needle tip. After obtaining approximately 2–4 cc of PRP from the first tube, the second tube will be processed in the same manner (yielding a total of 4–8 cc of PRP). The collected solution will be transferred to a resuspension tube and gently agitated for 30 seconds to 1 minute. The injection protocol will be detailed in the relevant section. Intervention 2: Second Intervention Group: Stem Cell-Treated Group. Preparation and Isolation of Stem Cells:Menstrual blood-derived stem cells (MenSCs) from patients in the treatment group will be collected using sterile menstrual cups on the second day of menstruation. The number of antral follicles will be measured via vaginal ultrasound.The samples will then be placed in collection tubes containing phosphate-buffered saline (PBS) without Ca²⁺ or Mg²⁺ (GMP-grade), supplemented with:100 µg/mL streptomycin,2.5 mg/mL amphotericin B (Fungizone),100 U/mL penicillin, and0.5 mg/mL EDTA.The samples will be immediately transferred to a Class B cleanroom for mesenchymal stem cell (MSC) isolation and culture. The injection protocol will be detailed in the relevant section. Intervention 3: Control group: observation (no treatment). No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information is available.
public Mina Ataee
Karaj, Shohada Sq, Kamali Hospital
Karaj Iran (Islamic Republic of) 7561948637 +98 26 3300 8465 ataee.mina@yahoo.com Alborz University of Medical Sciences scientific Mina Ataee
Karaj, Shohada Sq, Kamali Hospital
Karaj Iran (Islamic Republic of) 7561948637 +98 26 3300 8465 ataee.mina@yahoo.com AlborzUniversity of Medical Sciences Iran (Islamic Republic of) Diagnosis of poor ovarian response (history of one ovulation stimulation cycle with fewer than 4 eggs,Anti-Müllerian Hormone(AMH) below 1.1, and Follicle-stimulating hormone(FSH) less than 20) 20 years 40 years Female Age over 40 years and under 20 years Having at least one of the following conditions: endometriosis, severe oligospermia, hydrosalpinx, kidney disease, liver disease, diabetes, thyroid and autoimmune diseases, history of local allergic reactions, benign intracranial hypertension, history of cancer, patients with fibrocystic breasts and recurrent fibroids and adenomyosis, systemic immune diseases, and chronic inflammation of the endometrium, cervix, and infections N97.0 Female infertility associated with anovulation Treatment - Drugs Treatment - Drugs N/A First Intervention Group: Platelet-Rich Plasma (PRP) Recipient GroupThe preparation of PRP (platelet-rich plasma) will involve plasma separation via centrifugation. Approximately 20 mL of blood will be drawn under sterile conditions, and PRP will be prepared using an autologous platelet-rich plasma kit according to the manufacturer's protocol.In summary, after blood collection, the tubes will be centrifuged at 830 × *g* for 8 minutes. A 16-gauge needle attached to a 5-mL syringe will then be inserted into the tube, advancing just above the buffy coat layer. The PRP will be collected by rotating the needle tip. After obtaining approximately 2–4 cc of PRP from the first tube, the second tube will be processed in the same manner (yielding a total of 4–8 cc of PRP). The collected solution will be transferred to a resuspension tube and gently agitated for 30 seconds to 1 minute. The injection protocol will be detailed in the relevant section. Second Intervention Group: Stem Cell-Treated Group. Preparation and Isolation of Stem Cells:Menstrual blood-derived stem cells (MenSCs) from patients in the treatment group will be collected using sterile menstrual cups on the second day of menstruation. The number of antral follicles will be measured via vaginal ultrasound.The samples will then be placed in collection tubes containing phosphate-buffered saline (PBS) without Ca²⁺ or Mg²⁺ (GMP-grade), supplemented with:100 µg/mL streptomycin,2.5 mg/mL amphotericin B (Fungizone),100 U/mL penicillin, and0.5 mg/mL EDTA.The samples will be immediately transferred to a Class B cleanroom for mesenchymal stem cell (MSC) isolation and culture. The injection protocol will be detailed in the relevant section. Control group: observation (no treatment) Positive serum B-Human Chorionic Gonadotropin (hCG) test. Timepoint: 4, 8, 12 weeks after intervention. Method of measurement: Electrochemiluminescence immunoassay (ECLIA). Alborz University of Medical Sciences Approved 2025-05-24 Ethics committee of Alborz University of Medical Sciences No. 45, Safarzade St, Golshahr, Karaj Karaj Alborz Iran (Islamic Republic of)