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

Acibadem University

Status: Completed

Conditions: Diminished Ovarian Reserve; Premature Ovarian Failure

Treatments: Biological: PRP injection into at least one ovary

Study type: Interventional

Funder types: Other

Identifiers

NCT04237909

ATADEK 2019/8-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 patients

Sex: Female

Ages: 20 to 48 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Ovarian Reserve

Experimental group

Description:

Patients with diminished ovarian reserve or premature ovarian insufficiency

Treatment:

Biological: PRP injection into at least one ovary