Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

Not Applicable

• Conditions: Primary Ovarian Insufficiency

• Registration Number: NCT03034616
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The OLIVA device will enable to perform shallow slashes on the ovarian cortex in patients undergoing oophorectomy. Prior to the resection of the ovary from the pedicle we will perform 5 parallel slashes 3 cm long. following oophorectomy investigation by the pathologist as to the depth of cuts and proximity to blood vessels and later.

Detailed Description

The OLIVA device is built of 5 parallel razor blades enclosed by protective cap

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-26
• Last Update Submitted: 2017-01-26
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion Criteria

• Women with ovarian malignancy
• Women with polycystic ovarian syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depth of cuts and closeness to blood vessel	Up to 30 days after procedure	The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device

Secondary Outcome Measures

Name	Time	Method
Proximity of cuts to blood vessel	Up to 30 days after procedure	The pathologist will measure the ovarian tissue after oophorectomy. The pathologist will assess whether the cuts into the cortex are superficial or penetrating the cortex into the medulla of the ovary. Another assessment is proximity of the cuts to ovarian vessels. The pathology report will aggregate the results of all measurements and will assess the safety of the OLIVA device