Effects of Intraovarian Injection of Autologous Platelet Rich Plasma on Ovarian Reserve and IVF Outcome Parameters in Women With Premature Ovarian Insufficiency and Poor Ovarian Response
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ovarian Failure
- Sponsor
- Acibadem University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Ovarian reserve parameters
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Reproductive age women diagnosed with poor ovarian response (POR) based on Poseidon criteria and premature ovarian insufficiency (POI) based on ESHRE criteria and with a history of at least one prior failed IVF 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 at least one ovary. Ovarian reserve parameters and IVF outcomes will be determined.
Detailed Description
Reproductive age women diagnosed with POR based on Poseidon criteria and POI based on European Society of Human Reproduction and Endocrinology (ESHRE) criteria with a history of at least one prior failed IVF 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 35 cm 17 G needle under transvaginal ultrasound guidance. On the 2-4th days of the first six 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 in-vitro fertilization- intracytoplasmic sperm injection (IVF-ICSI), followed by embryo banking/ preimplantation genetic testing- aneuploidy (PGT-A) or embryo transfer. Markers of ovarian reserve (AFC, FSH, AMH), and IVF laboratory outcome parameters (number of metaphase II (MII) oocytes, 2PN(pronucleus) embryos, cleavage stage, blastocyst embryos) will be followed.
Investigators
Bulent Tiras
Prof.
Acibadem University
Eligibility Criteria
Inclusion Criteria
- •Patients with a history of \>1 year infertility duration with at least one ovary, who fulfilled the ESHRE criteria,
- •Patients diagnosed with POR based on Poseidon criteria and with a history of at least one prior failed IVF cycle
Exclusion Criteria
- •Presence of pregnancy,
- •previous diagnosis of any malignancy,
- •ovarian insufficiency secondary to sex chromosome etiology,
- •prior major lower abdominal surgery resulting in pelvic adhesions,
- •anticoagulant use for which plasma infusion is contraindicated,
- •current or previous (Immunoglobulin A (IgA) deficiency
Outcomes
Primary Outcomes
Ovarian reserve parameters
Time Frame: 6 months
Number of participants with intraovarian injection of autologous PRP as assessed by blood hormone analysis and ultrasonographic antral follicle counts, change in serum FSH, AMH levels and number of antral follicle counts.
Secondary Outcomes
- Ovarian response to stimulation(12 months)