Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Infertility, Female Clinical Trial

— TESOVA2022  

Official title:

Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06261658
• Other study ID #: TESOVA2022
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 29, 2033

Study information

• Verified date: February 2024
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Diego Raimondo, MD
• Phone: 0512143732
• Email: die.raimondo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is aimed to evaluate the effects of intraovarian injection of autologous Platelet-enriched Autologous Plasma on the outcomes of orthotopic transplantation of cryopreserved ovarian tissue.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 29, 2033
• Est. primary completion date: December 29, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• request for cryopreserved ovarian tissue transplantation;
• premature ovarian failure or irregular mentrual cycles;
• negative test for HIV, HBV, HCV, Treponema pallidum;
• negative PAP test;
• oncological authorization;
• absence of neoplastic contamination in the cryopreserved ovarian tissue;
• Informed consent

Exclusion Criteria:

• neoplastic contamination in cryopreserved ovarian tissue;
• history of endometriosis;
• endocrinological disorders present and not treated (uncompensated thyroid dysfunction, diabetes (type 1, type 2);
• body mass index (BMI) >30 kg/m2;
• circulating platelet level < 150,000 / mml;
• bacterial infection;
• ongoing use of anticoagulants;
• bleeding diathesis.

Related Conditions & MeSH terms

• Cryopreservation
• Infertility
• Infertility, Female
• Menopause Ovarian Failure
• Ovary Injury

Intervention

Procedure:
• Cryopreserved Ovarian Tissue Reimplantation
Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Locations

Country	Name	City	State
Italy	Diego Raimondo	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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

Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22. — View Citation

Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22. — View Citation

Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17. — View Citation

Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma	to evaluate the safety of intraovarian PRP injection in terms of absence of adverse reactions to laparoscopic ovarian tissue reimplantation surgery. Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure.	first year
Secondary	Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma	to evaluate whether the use of autologous PRP during the ovarian tissue transplantation leads to an improvement of outcomes in terms of ovarian function recovery (endocrine and reproductive functions). Patients in early menopause or with irregular menstrual cycles who have cryopreserved their ovarian tissue at the Cryobank of Division of Gynaecology and Human Reproduction Physiopathology, IRCCS Azienda Ospedaliero-Universitaria di Bologna will be recruited. These patients will be joined by a historical cohort of patients who have the inclusion criteria of this study and who have already undergone reimplantation of ovarian tissue as the routine clinical care procedure.	9 years