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

NCT ID: NCT06261658

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2033-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Cryopreservation Ovary Injury Infertility, Female Menopause Ovarian Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Group Type EXPERIMENTAL

Cryopreserved Ovarian Tissue Reimplantation

Intervention Type PROCEDURE

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Interventions

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Cryopreserved Ovarian Tissue Reimplantation

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role lead

Responsible Party

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Renato Seracchioli

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Diego Raimondo, MD

Role: STUDY_CHAIR

IRCCS AOU Bologna

Locations

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Diego Raimondo

Bologna, BO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Diego Raimondo, MD

Role: CONTACT

0512143732

Facility Contacts

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Diego Raimondo, MD

Role: primary

0512144389 ext. 0039

References

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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.

Reference Type BACKGROUND
PMID: 32700285 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29564738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33886116 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33723748 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35175511 (View on PubMed)

Other Identifiers

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TESOVA2022

Identifier Type: -

Identifier Source: org_study_id

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