Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response
Condition: Poor Ovarian Reserve
Study type: Interventional

Summary: 
      Reproductive age women diagnosed with poor ovarian response (POR) based on Bologna criteria
      with a history of at least two prior failed ICSI cycle will be recruited for the study.
      Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular phase
      serum follicle stimulating hormone (FSH) levels will determined at baseline. Autologous blood
      obtained from peripheral vein will be used to prepare PRP following standard protocols and
      will be injected to both ovaries. Ovarian reserve parameters and ICSI outcomes will be
      determined.
    

Detailed description: 
      Reproductive age women diagnosed with POR based on Bologna criteria with a history of at
      least two prior failed intracytoplasmic sperm injection (ICSI) cycle will recruited for the
      study. Antral follicle count (AFC), serum anti-mullerian hormone (AMH), and early follicular
      phase serum follicle stimulating hormone (FSH) levels will be determined at baseline.
      Autologous blood obtained from peripheral vein will be used to prepare PRP following standard
      protocols. PRP injection will be performed under sedation anesthesia, using a 11.8 inch (30
      cm) single lumen 21G needles under transvaginal ultrasound guidance. On the 2 to 4th days of
      the first three menstrual cycles following the procedure, AFC, AMH, and FSH levels will be
      re-assessed. Patients with at least one antral follicle will be started on ovarian
      stimulation for ICSI, followed by embryo transfer. Biomarkers of ovarian reserve (AFC, FSH,
      AMH), and ICSI outcome parameters (number of metaphase II (MII) oocytes, blastocyst embryos,
      fertilization rate, oocyte and embryo quality) will be followed.
    

Intervention name(s): Autologous ovarian PRP injection
Intervention type(s): Biological
Intervention description(s): The same day, within 1 hour of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into both ovaries using 11.8 inch (30 cm) single lumen 21G needles. The ovaries will be reached using needle guide preventing vascular or other structures rupture. The needle will be advanced into the centre of the ovarian medula without rotation. The correct tip placement will be confirmed by ultrasound. The activated PRP will be slowly introduced during careful retraction of the needle across the previously traversed ovarian cortex. The final PRP volume will be deposited under the ovarian capsule and the needle exit the ovary. Approximately 0.5 ml of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30 minutes and also be discharged home on the same day.
Intervention model: Single Group Assignment
Intervention model description: After the women are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle after treatment. Approximately 22 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 1 hour of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into both ovaries. Ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of MII oocytes, fertilization rate, oocyte and embryo quality) will be followed up to three months after the intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Platelet-Rich Plasma; Poor Ovarian Reserve; Oocyte Quality; Embryo Quality