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

Poor Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04797377
• Other study ID #: 022019
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: September 4, 2021

Study information

• Verified date: April 2022
• Source: Nadezhda Women's Health Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 4, 2021
• Est. primary completion date: September 4, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Poor Ovarian Reserve

Intervention

Biological:
• Autologous ovarian PRP injection
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.

Locations

Country	Name	City	State
Bulgaria	Nadezhda Women's Health Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Nadezhda Women's Health Hospital

Country where clinical trial is conducted

Bulgaria, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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). pii: E7794. doi: 10.3390/ijms21207794. Review. — View Citation

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. Review. — View Citation

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). pii: BSR20190805. doi: 10.1042/BSR20190805. Print 2019 Jun 28. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oocyte number	Number of Metaphase II oocyte yield.	3 months
Primary	Oocyte quality	Oocytes will be classified based on morphological assessment and enumeration of extracytoplasmic anomalies.	3 months
Primary	Embryo number	Number of produced embryos per cycle.	3 months
Primary	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
Primary	Fertilization rate	Fertilization rate will be calculated as the percentage of transformation of the injected oocytes into two pronuclei.	3 months
Secondary	Antral follicle count (AFC)	Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of the cycle.	3 months
Secondary	Serum anti-mullerian hormone (AMH)	Serum concentration of anti-mullerian hormone determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.	3 months
Secondary	Serum follicle stimulating hormone (FSH)	Serum concentration of follicle stimulating hormone (FSH) levels determined on day 3 of the cycle by an electrochemiluminescent (ECLIA) immunoanalyzer.	3 months