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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

request for cryopreserved ovarian tissue transplantation;

premature ovarian failure or irregular mentrual cycles;

negative test for HIV, HBV, HCV, Treponema pallidum;

negative PAP test;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cryopreserved Ovarian Tissue Reimplantation

    Procedure/Surgery

    Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Study groupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
first year

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

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