Autologous Intraovarian Platelet Rich Plasma Treatment in Women With Poor Ovarian Response

Nadezhda Women's Health Hospital

Status: Completed

Conditions: Poor Ovarian Reserve

Treatments: Biological: Autologous ovarian PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04797377

022019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: Female

Ages: 30 to 46 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with POR based on Bologna criteria and with a history of at least two prior failed ICSI cycles
• A previous assisted reproductive technology cycle with less than 3 oocytes (conventional stimulation protocol) and AFC < 7
• The same ovarian stimulation protocol before and after the PRP treatment

Exclusion criteria

• Age over 46 years,
• Body mass index (BMI) ≥ 30 kg/m2,
• Presence of pregnancy
• Uncontrolled endocrine disorders (polycystic ovary syndrome and others)
• Parental genetic and chromosomal disorders,
• Immunological disorders
• Cancer diagnostics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Ovarian Reserve

Experimental group

Description:

Patients with diminished ovarian reserve or premature ovarian insufficiency

Treatment:

Biological: Autologous ovarian PRP injection