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NCT Number: NCT04797377

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

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.

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Key information

Conditions

Poor Ovarian Reserve

Age range

30 year–46 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nadezhda Women's Health Hospital

Sofia, 1373, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous ovarian PRP injection

Biological

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.

Primary outcomes

  1. Oocyte number

    Time frame: 3 months

    Number of Metaphase II oocyte yield.

  2. Oocyte quality

    Time frame: 3 months

    Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.

  3. Embryo number

    Time frame: 3 months

    Number of produced embryos per cycle.

  4. Embryo quality

    Time frame: 3 months

    Morphological evaluation of the cultured embryos will be conducted 120 or 144 hr following sperm injection. Blastocysts scoring will be performed on day 5 or 6 depending on the blastocoel cavity expansion and on the inner cell mass and trophectoderm cells integrity.

  5. Fertilization rate

    Time frame: 3 months

    Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.

Secondary outcomes

  1. Antral follicle count (AFC)

    Time frame: 3 months

    Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of the cycle.

  2. Serum anti-mullerian hormone (AMH)

    Time frame: 3 months

    Serum concentration of anti-mullerian hormone determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.

  3. Serum follicle stimulating hormone (FSH)

    Time frame: 3 months

    Serum concentration of follicle stimulating hormone (FSH) levels determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.

Sponsors and collaborators

Lead sponsor

Nadezhda Women's Health Hospital

Other

Registry information

Official study title

Effects of Autologous Intraovarian Platelet Rich Plasma in Women With Poor Ovarian Response

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 15, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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