OncologyNCT05134090
Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.
An observational study of Oncology and Fertility Issues, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oncology, Fertility Issues, Surgery
- What is being tested?
- Ovaian tissue explant
- Type of treatment
- Medical device
- How many people
- 59 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2021to 1 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with histological diagnosis of malignancy during reproductive age undergoing ovarian tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.
Who may be able to join
- Oncologic women with desire to preserve fertility
Who cannot join
- Ovarian explant with different techniques than laparoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.
Read the detailed description
This is a retrospective analysis to evaluate the efficacy and safety of percutaneous laparoscopy for the ovarian tissue explant in oncologic women. Surgical outcomes of patients that underwent percutaneous laparoscopy were compared with those of women that underwent conventional laparoscopy. Data from 2017 to 2021 were collected in a single Oncologic Center in Italy. The principal outcomes considered are post-operative pain, recovery time and aesthetic outcomes.
- Conditions
- Oncology, Fertility Issues, Surgery
- Being tested
- Ovaian tissue explant
- Keywords
- Percuvataneous laparoscopy, Ovarian Tissue Cryopreservation
- Medical subject headings
- Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovaian tissue explantDevice
Ovarian tissue explant for cryopreservation of ovarian tissue
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous laparoscopy | Laparoscopy with percutaneous grasp (2.9 mm). Receives: Device: Ovaian tissue explant | |
| Conventional laparoscopy | Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm). Receives: Device: Ovaian tissue explant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain is evaluated with VAS score ranging from 1 to 10 (higher score, maximum pain)
Measured: 0-1 and 2 days after surgery
Aesthetic outcomes
General satisfaction regarding aesthetic outcomes is collected with a satisfaction survey. The score ranged from 1 to 5, with 1 indicating "very dissatisfied" and 5 "very satisfied".
Measured: minimum 3 months after surgery
Secondary outcomes (4)
Recovery time
Time from surgical intervention to discharge in days
Measured: Days
Operative time
Time of operation in minutes
Measured: 1 day
Blood loss
Entity of blood loss during surgery in ml
Measured: 1 day
Surgical complications
The presence of absence of intra and post-operative complications (yes or not and type)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start10 May 2021
- Primary completion1 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OncologyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benito Chiofalo, Regina Elena Cancer Institute
- Investigators
- Benito Chiofalo, Principal investigator, IRCCS "Regina Elena" National Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134090
- Sponsor's protocol ID
- 1514/21
- Status last verified
- Nov 2021
- First submitted
- 11 Aug 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chiofalo B, Bruno V, Calandra M, Savone D, Mancini E, Baiocco E, Iacobelli M, Giannini A, Vizza E. Percutaneous-assisted laparoscopy for ovarian tissue cryopreservation: a single-center experience. Arch Gynecol Obstet. 2022 Oct;306(4):1329-1335. doi: 10.1007/s00404-022-06684-0. Epub 2022 Jul 10.
PubMed 35819490
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.
- ClinicalTrials.gov ID
- NCT05134090
- Acronym / sponsor ID
- 1514/21
- Conditions
- Oncology, Fertility Issues, Surgery
- Keywords
- Percuvataneous laparoscopy, Ovarian Tissue Cryopreservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 24 Nov 2021 (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.
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.
Detailed description
This is a retrospective analysis to evaluate the efficacy and safety of percutaneous laparoscopy for the ovarian tissue explant in oncologic women. Surgical outcomes of patients that underwent percutaneous laparoscopy were compared with those of women that underwent conventional laparoscopy. Data from 2017 to 2021 were collected in a single Oncologic Center in Italy. The principal outcomes considered are post-operative pain, recovery time and aesthetic outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Percutaneous laparoscopy | – | Device: Ovaian tissue explantLaparoscopy with percutaneous grasp (2.9 mm). |
| Conventional laparoscopy | – | Device: Ovaian tissue explantConventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm). |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with histological diagnosis of malignancy during reproductive age undergoing ovarian tissue explant for ovarian tissue cryopreservation, from Aug 2017 to Jun 2021.
Key inclusion criteria (1 listed)
- Oncologic women with desire to preserve fertility
Key exclusion criteria (1 listed)
- Ovarian explant with different techniques than laparoscopy
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 |
|---|---|---|
| Ovaian tissue explantOvarian tissue explant for cryopreservation of ovarian tissue | Device | Conventional laparoscopy, Percutaneous laparoscopy |
Primary outcome
Post-operative pain
Time frame: 0-1 and 2 days after surgery
Post-operative pain is evaluated with VAS score ranging from 1 to 10 (higher score, maximum pain)
Aesthetic outcomes
Time frame: minimum 3 months after surgery
General satisfaction regarding aesthetic outcomes is collected with a satisfaction survey. The score ranged from 1 to 5, with 1 indicating "very dissatisfied" and 5 "very satisfied".
4 secondary outcomes
Recovery time
Time frame: Days
Operative time
Time frame: 1 day
Blood loss
Time frame: 1 day
Surgical complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Derived from this study: PubMed 35819490Chiofalo B, Bruno V, Calandra M, Savone D, Mancini E, Baiocco E, Iacobelli M, Giannini A, Vizza E. Percutaneous-assisted laparoscopy for ovarian tissue cryopreservation: a single-center experience. Arch Gynecol Obstet. 2022 Oct;306(4):1329-1335. doi: 10.1007/s00404-022-06684-0. Epub 2022 Jul 10.
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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. This study is not recruiting at the moment.
Benito Chiofalo principal investigator
IRCCS "Regina Elena" National Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology and Fertility Issues, run by Regina Elena Cancer Institute 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 24 Nov 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 0-1 and 2 days after surgery). The study lists 2 primary outcomes in all. 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 NCT05134090, which also lists 1 linked publication.
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 24 Nov 2021.