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

NCT06261658 | Recruiting

• 1 other identifier: TESOVA2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cryopreserved Ovarian Tissue; Ovarian tissue transplantation; Platelet-enriched Autologous Plasma; ovarian endocrine function; livebirths

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma

  9 years

Study Arms (1)

Study group

EXPERIMENTAL

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Procedure: Cryopreserved Ovarian Tissue Reimplantation

Interventions

Cryopreserved Ovarian Tissue Reimplantation PROCEDURE

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Diego Raimondo

Bologna, BO, 40138, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 32700285 BACKGROUND

• 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.

  PMID: 29564738 BACKGROUND

• 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.

  PMID: 33886116 BACKGROUND

• 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.

  PMID: 33723748 BACKGROUND

• 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.

  PMID: 35175511 BACKGROUND

• Ferla S, Fucina S, Clemente N, Spessotto P, Cannizzaro R, Ditto A. Probe-Based Confocal Laser Endomicroscopy in Gynecologic Surgical Oncology: Intraoperative Insights to Guide Surgical Resection. Ann Surg Oncol. 2026 Jan 14. doi: 10.1245/s10434-025-19055-1. Online ahead of print.

  PMID: 41535563 DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Diego Raimondo, MD

  IRCCS AOU Bologna

  STUDY CHAIR

Central Study Contacts

Diego Raimondo, MD

CONTACT

0512143732; die.raimondo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: March 1, 2024
• Primary Completion: December 29, 2024
• Study Completion (Estimated): December 29, 2033
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

IT (1)