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Percutaneous Laparoscopy for Ovarian Tissue Cryopreservation.

NCT ID: NCT05134090

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2021-08-01

Brief Summary

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

Detailed Description

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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

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Oncology Fertility Issues Surgery

Keywords

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Percuvataneous laparoscopy Ovarian Tissue Cryopreservation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Percutaneous laparoscopy

Laparoscopy with percutaneous grasp (2.9 mm).

Ovaian tissue explant

Intervention Type DEVICE

Ovarian tissue explant for cryopreservation of ovarian tissue

Conventional laparoscopy

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

Ovaian tissue explant

Intervention Type DEVICE

Ovarian tissue explant for cryopreservation of ovarian tissue

Interventions

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Ovaian tissue explant

Ovarian tissue explant for cryopreservation of ovarian tissue

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Oncologic women with desire to preserve fertility

Exclusion Criteria

* Ovarian explant with different techniques than laparoscopy
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regina Elena Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Benito Chiofalo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benito Chiofalo

Role: PRINCIPAL_INVESTIGATOR

IRCCS "Regina Elena" National Cancer Institute

Locations

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IRCCS "Regina Elena" National Cancer Institute

Rome, Lazio, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 35819490 (View on PubMed)

Other Identifiers

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1514/21

Identifier Type: -

Identifier Source: org_study_id