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

NCT04797377 | Completed

• 1 other identifier: 022019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Poor Ovarian Reserve

Keywords

Platelet-Rich Plasma; Poor Ovarian Reserve; Oocyte Quality; Embryo Quality

Outcome Measures

Primary Outcomes (5)

• Oocyte number

  Number of Metaphase II oocyte yield.

  3 months

• Oocyte quality

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

  3 months

• Embryo number

  Number of produced embryos per cycle.

  3 months

• Embryo quality

  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.

  3 months

• Fertilization rate

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

  3 months

Secondary Outcomes (3)

• Antral follicle count (AFC)

  3 months

• Serum anti-mullerian hormone (AMH)

  3 months

• Serum follicle stimulating hormone (FSH)

  3 months

Study Arms (1)

Ovarian Reserve

EXPERIMENTAL

Patients with diminished ovarian reserve or premature ovarian insufficiency

Biological: Autologous ovarian PRP injection

Interventions

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.

Ovarian Reserve

Eligibility Criteria

• Age: 30 Years - 46 Years
• Gender Eligibility Details: Based on gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nadezhda Women's Health Hospital: lead

Study Sites (1)

Nadezhda Women's Health Hospital

Sofia, 1373, Bulgaria

Location

Related Publications (7)

• Drakopoulos P, Bardhi E, Boudry L, Vaiarelli A, Makrigiannakis A, Esteves SC, Tournaye H, Blockeel C. Update on the management of poor ovarian response in IVF: the shift from Bologna criteria to the Poseidon concept. Ther Adv Reprod Health. 2020 Jul 31;14:2633494120941480. doi: 10.1177/2633494120941480. eCollection 2020 Jan-Dec.

  PMID: 32844159 BACKGROUND

• Zhang Y, Zhang C, Shu J, Guo J, Chang HM, Leung PCK, Sheng JZ, Huang H. Adjuvant treatment strategies in ovarian stimulation for poor responders undergoing IVF: a systematic review and network meta-analysis. Hum Reprod Update. 2020 Feb 28;26(2):247-263. doi: 10.1093/humupd/dmz046.

  PMID: 32045470 BACKGROUND

• Panda SR, Sachan S, Hota S. A Systematic Review Evaluating the Efficacy of Intra-Ovarian Infusion of Autologous Platelet-Rich Plasma in Patients With Poor Ovarian Reserve or Ovarian Insufficiency. Cureus. 2020 Dec 12;12(12):e12037. doi: 10.7759/cureus.12037.

  PMID: 33457137 BACKGROUND

• Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794.

  PMID: 33096812 BACKGROUND

• Sills ES, Wood SH. Autologous activated platelet-rich plasma injection into adult human ovary tissue: molecular mechanism, analysis, and discussion of reproductive response. Biosci Rep. 2019 Jun 4;39(6):BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28.

  PMID: 31092698 BACKGROUND

• Bos-Mikich A, de Oliveira R, Frantz N. Platelet-rich plasma therapy and reproductive medicine. J Assist Reprod Genet. 2018 May;35(5):753-756. doi: 10.1007/s10815-018-1159-8. Epub 2018 Mar 21.

  PMID: 29564738 BACKGROUND

• Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.

  PMID: 29457008 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After the women are recruited for the study, Antral follicle count (AFC), serum anti-mullerian hormone (AMH) and follicle stimulating hormone (FSH) levels will be determined at baseline and will be repeated beginning with the first menstrual cycle after treatment. Approximately 22 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. 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. Ovarian reserve (AFC, FSH, AMH), and ICSI outcome parameters (number of MII oocytes, fertilization rate, oocyte and embryo quality) will be followed up to three months after the intervention.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 15, 2021
• Study Start: March 16, 2021
• Primary Completion: September 4, 2021
• Study Completion: September 4, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)