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

Not Applicable

Recruiting

• Conditions: Cryopreservation; Infertility, Female; Menopause Ovarian Failure; Ovary Injury
• Interventions: Procedure: Cryopreserved Ovarian Tissue Reimplantation

• Registration Number: NCT06261658
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-15
• Last Update Posted: 2024-02-15
• Study Start: 2024-03-01
• Primary Completion: 2024-12-29
• Study Completion: 2033-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group	Cryopreserved Ovarian Tissue Reimplantation	Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Primary Outcome Measures

Name	Time	Method
Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma	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.

Secondary Outcome Measures

Name	Time	Method
Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma	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.

Trial Locations

Locations (1)

Diego Raimondo; 🇮🇹 Bologna, BO, Italy