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 PRP and stem cells injection

The stem cell-treated group, the platelet-rich plasma-treated group, and the untreated (control) group

Administration method of PRP and stem cells: Intraovarian injection will be performed in the operating room under conscious sedation within two hours after PRP and stem cell preparation. Based on the patient's study group assignment, either PRP or stem cells will be injected into at least one ovary using a 35-cm 17G single-lumen needle under ultrasound-guided vaginal approach. Although ovaries in advanced maternal age patients with POR may be small and fibrotic, the injection will be achieved by creating new planes within the ovary through dilation and multi-site injections. Patients will be transferred to the recovery room post-procedure and discharged home the same day after 30-40 minutes of observation.

Inclusion: Diagnosis of poor ovarian response (history of one ovulation stimulation cycle with fewer than 4 eggs, AMH below 1.1, and FSH less than 20) Exclusion: 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

1. Platelet-rich plasma (PRP) 2. Stem cells 3. No treatment (control) (Due to word limitations, preparation details cannot be included)

Chemical Pregnancy ( positive serum B-hCG test)

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.

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

No further information is available.