Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

Surgery Clinical Trial

Official title:

Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation: a Single-center Experience.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134090
• Other study ID #: 1514/21
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2021
• Source: Regina Elena Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Oncologic women with desire to preserve fertility

Exclusion Criteria:

• Ovarian explant with different techniques than laparoscopy

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Oncology
• Surgery

Intervention

Device:
• Ovaian tissue explant
Ovarian tissue explant for cryopreservation of ovarian tissue

Locations

Country	Name	City	State
Italy	IRCCS "Regina Elena" National Cancer Institute	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recovery time	Time from surgical intervention to discharge in days	Days
Secondary	Operative time	Time of operation in minutes	1 day
Secondary	Blood loss	Entity of blood loss during surgery in ml	1 day
Secondary	Surgical complications	The presence of absence of intra and post-operative complications (yes or not and type)	30 days