NCT05134090

Brief Summary

To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

August 11, 2021

Last Update Submit

November 15, 2021

Conditions

OncologyFertility IssuesSurgery

Keywords

Percuvataneous laparoscopyOvarian Tissue Cryopreservation

Outcome Measures

Primary Outcomes (2)

  • Post-operative pain

    Post-operative pain is evaluated with VAS score ranging from 1 to 10 (higher score, maximum pain)

    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".

    minimum 3 months after surgery

Secondary Outcomes (4)

  • Recovery time

    Days

  • Operative time

    1 day

  • Blood loss

    1 day

  • Surgical complications

    30 days

Study Arms (2)

Percutaneous laparoscopy

Laparoscopy with percutaneous grasp (2.9 mm).

Device: Ovaian tissue explant

Conventional laparoscopy

Conventional laparoscopy with conventional laparoscopic trocars (10 or 5 mm).

Device: Ovaian tissue explant

Interventions

Ovaian tissue explantDEVICE

Ovarian tissue explant for cryopreservation of ovarian tissue

Conventional laparoscopyPercutaneous laparoscopy

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Oncologic women with desire to preserve fertility

You may not qualify if:

  • Ovarian explant with different techniques than laparoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS "Regina Elena" National Cancer Institute

Rome, Lazio, 00144, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35819490DERIVED

MeSH Terms

Conditions

NeoplasmsInfertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Benito Chiofalo

    IRCCS "Regina Elena" National Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2021

First Posted

November 24, 2021

Study Start

May 10, 2021

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

IT(1)