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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06261658
Other study ID # TESOVA2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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