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NCT Number: NCT06261658

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

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.

Recruiting

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Diego Raimondo

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Diego Raimondo, MD

CONTACT

[email protected]

0512144389 ext. 0039

Diego Raimondo, MD

SUB_INVESTIGATOR

Renato Seracchioli, MD

PRINCIPAL_INVESTIGATOR

Rossella Vicenti, PhD

SUB_INVESTIGATOR

Valentina Magnani, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryopreserved Ovarian Tissue Reimplantation

Procedure

Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diego Raimondo, MD

CONTACT

[email protected]

0512143732

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: TESOVA2022

Important dates

Study start
2024
Primary completion
2024
Study completion
2033
First posted
Feb 15, 2024
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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