CryopreservationTESOVA2022NCT06261658
Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
A study testing Cryopreserved Ovarian Tissue Reimplantation in people with Cryopreservation and Ovary Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cryopreservation, Ovary Injury, Infertility, Female
- What is being tested?
- Cryopreserved Ovarian Tissue Reimplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 29 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Diego Raimondo
Bologna, BO, 40138
Diego Raimondo, MD, 0512144389 ext. 0039, die.raimondo@gmail.com
Renato Seracchioli, MD
About this study
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.
- Being tested
- Cryopreserved Ovarian Tissue Reimplantation
- Keywords
- Cryopreserved Ovarian Tissue, Ovarian tissue transplantation, Platelet-enriched Autologous Plasma, ovarian endocrine function, livebirths
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryopreserved Ovarian Tissue ReimplantationProcedure or surgery
Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma Receives: Procedure: Cryopreserved Ovarian Tissue Reimplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start1 Mar 2024 (estimated)
- Primary completion29 Dec 2024 (estimated)
- Study completion29 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CryopreservationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renato Seracchioli, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Diego Raimondo, MD, Study chair, IRCCS AOU Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261658
- Sponsor's protocol ID
- TESOVA2022
- Acronym
- TESOVA2022
- Status last verified
- Feb 2024
- First submitted
- 8 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22.
PubMed 32700285Bos-Mikich A, de Oliveira R, Frantz N. Platelet-rich plasma therapy and reproductive medicine. J Assist Reprod Genet. 2018 May;35(5):753-756. doi: 10.1007/s10815-018-1159-8. Epub 2018 Mar 21.
PubMed 29564738Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22.
PubMed 33886116Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15.
PubMed 33723748Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
PubMed 35175511Ferla S, Fucina S, Clemente N, Spessotto P, Cannizzaro R, Ditto A. Probe-Based Confocal Laser Endomicroscopy in Gynecologic Surgical Oncology: Intraoperative Insights to Guide Surgical Resection. Ann Surg Oncol. 2026 Apr;33(4):3512-3513. doi: 10.1245/s10434-025-19055-1. Epub 2026 Jan 14.
PubMed 41535563
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Cryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma
- ClinicalTrials.gov ID
- NCT06261658
- Acronym / sponsor ID
- TESOVA2022 / TESOVA2022
- Keywords
- Cryopreserved Ovarian Tissue, Ovarian tissue transplantation, Platelet-enriched Autologous Plasma, ovarian endocrine function, livebirths
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 29 Dec 2033 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Cryopreserved Ovarian Tissue ReimplantationCryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryopreserved Ovarian Tissue ReimplantationCryopreserved Ovarian Tissue Reimplantation Using Platelet-enriched Autologous Plasma | Procedure or surgery | Study group |
Primary outcome
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.
1 secondary outcome
Effectiveness of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma
Time frame: 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 32700285Petryk N, Petryk M. Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Reprod Sci. 2020 Nov;27(11):1975-1982. doi: 10.1007/s43032-020-00266-8. Epub 2020 Jul 22.
- Background: PubMed 29564738Bos-Mikich A, de Oliveira R, Frantz N. Platelet-rich plasma therapy and reproductive medicine. J Assist Reprod Genet. 2018 May;35(5):753-756. doi: 10.1007/s10815-018-1159-8. Epub 2018 Mar 21.
- Background: PubMed 33886116Mouanness M, Ali-Bynom S, Jackman J, Seckin S, Merhi Z. Use of Intra-uterine Injection of Platelet-rich Plasma (PRP) for Endometrial Receptivity and Thickness: a Literature Review of the Mechanisms of Action. Reprod Sci. 2021 Jun;28(6):1659-1670. doi: 10.1007/s43032-021-00579-2. Epub 2021 Apr 22.
- Background: PubMed 33723748Sharara FI, Lelea LL, Rahman S, Klebanoff JS, Moawad GN. A narrative review of platelet-rich plasma (PRP) in reproductive medicine. J Assist Reprod Genet. 2021 May;38(5):1003-1012. doi: 10.1007/s10815-021-02146-9. Epub 2021 Mar 15.
- Background: PubMed 35175511Seckin S, Ramadan H, Mouanness M, Kohansieh M, Merhi Z. Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. J Assist Reprod Genet. 2022 Jan;39(1):37-61. doi: 10.1007/s10815-021-02385-w. Epub 2022 Feb 17.
- Derived from this study: PubMed 41535563Ferla S, Fucina S, Clemente N, Spessotto P, Cannizzaro R, Ditto A. Probe-Based Confocal Laser Endomicroscopy in Gynecologic Surgical Oncology: Intraoperative Insights to Guide Surgical Resection. Ann Surg Oncol. 2026 Apr;33(4):3512-3513. doi: 10.1245/s10434-025-19055-1. Epub 2026 Jan 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diego Raimondo, MD study chair
IRCCS AOU Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryopreserved Ovarian Tissue Reimplantation in people with Cryopreservation and Ovary Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diego Raimondo, MD (0512143732, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Cryopreserved ovarian tissue transplantation Using Platelet-enriched Autologous Plasma (time frame: first year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06261658, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.