Clinical trial NCT06261658: Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Official title: Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cryopreservation
Ovary Injury
Infertility, Female
Menopause Ovarian Failure
Keywords: Cryopreserved Ovarian Tissue
Ovarian tissue transplantation
Platelet-enriched Autologous Plasma
ovarian endocrine function
livebirths
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
timeFrame: first year
Secondary outcomes:
measure: Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
timeFrame: 9 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Diego Raimondo
state: BO
Study officials:
affiliation: IRCCS AOU Bologna
name: Diego Raimondo, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.