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

IRCCS Azienda Ospedaliero-Universitaria di Bologna45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cryopreservation Ovary Injury Infertility, Female Menopause Ovarian Failure

Interventions

Cryopreserved Ovarian Tissue ReimplantationPROCEDURE

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Diego Raimondo

Bologna, BO, Italy

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: first year

Secondary Outcomes

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

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.

Time frame: 9 years

Central Contacts

Diego Raimondo, MD

CONTACT

0512143732 die.raimondo@gmail.com

Data from ClinicalTrials.gov

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