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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

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

Treatments: Procedure: Cryopreserved Ovarian Tissue Reimplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT06261658

TESOVA2022

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Study group

Experimental group

Description:

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Treatment:

Procedure: Cryopreserved Ovarian Tissue Reimplantation