Effects of Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response and Premature Ovarian Insufficiency

Not Applicable

Completed

• Conditions: Diminished Ovarian Reserve; Premature Ovarian Failure
• Interventions: Biological: PRP injection into at least one ovary

• Registration Number: NCT04237909
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study First Submitted: 2020-01-12
• Study First Submitted QC: 2020-01-19
• Study First Posted: 2020-01-23
• Study Start: 2020-01-27
• Primary Completion: 2020-10-31
• Status Verified: 2020-11
• Study Completion: 2020-11-21
• Last Update Submitted: 2020-11-21
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ovarian Reserve	PRP injection into at least one ovary	Patients with diminished ovarian reserve or premature ovarian insufficiency

Primary Outcome Measures

Name	Time	Method
Ovarian reserve parameters	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 Outcome Measures

Name	Time	Method
Ovarian response to stimulation	12 months	Number of participants with intraovarian injection of autologous PRP as assessed by number antral follicle counts on ultrasound, eggs, and embryos in the laboratory, change from baseline in number of developing follicles, and percentage of obtained eggs and fertilized embryos.

Trial Locations

Locations (1)

Acıbadem University; 🇹🇷 Istanbul, Turkey