Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma (TESOVA2022)

February 8, 2024 updated by: Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40138
        • Recruiting
        • Diego Raimondo
        • Principal Investigator:
          • Renato Seracchioli, MD
        • Contact:
        • Sub-Investigator:
          • Diego Raimondo, MD
        • Sub-Investigator:
          • Rossella Vicenti, PhD
        • Sub-Investigator:
          • Valentina Magnani, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
Procedure: Cryopreserved Ovarian Tissue Reimplantation
Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
Time Frame: first year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
Time Frame: 9 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Investigators

  • Study Chair: Diego Raimondo, MD, Irccs Aou Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

December 29, 2024

Study Completion (Estimated)

December 29, 2033

Study Registration Dates

First Submitted

February 8, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESOVA2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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