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OpenTrials
Completed

NCT Number: NCT05134090

Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

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

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Key information

Conditions

Oncology Fertility Issues Genital Diseases Infertility Neoplasms Surgery Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS "Regina Elena" National Cancer Institute

Rome, Lazio, 00144, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Oncologic women with desire to preserve fertility

Exclusion criteria

  • Ovarian explant with different techniques than laparoscopy

Treatment and study plan

Ovaian tissue explant

Device

Ovarian tissue explant for cryopreservation of ovarian tissue

Primary outcomes

  1. 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)

  2. 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".

Secondary outcomes

  1. Recovery time

    Time frame: Days

    Time from surgical intervention to discharge in days

  2. Operative time

    Time frame: 1 day

    Time of operation in minutes

  3. Blood loss

    Time frame: 1 day

    Entity of blood loss during surgery in ml

  4. Surgical complications

    Time frame: 30 days

    The presence of absence of intra and post-operative complications (yes or not and type)

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 24, 2021
Registry last updated
Nov 24, 2021

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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