Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

Primary Ovarian Insufficiency Clinical Trial

— OLIVA  

Official title:

in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03034616
• Other study ID #: 029416
• Status: Not yet recruiting
• Phase: N/A
• First received: January 13, 2017
• Last updated: January 26, 2017
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: January 2017
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion Criteria:

• Women with ovarian malignancy

• Women with polycystic ovarian syndrome

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Turner Syndrome

Intervention

Device:
• OLIVA device
OLIVA device is a laparoscopic device with a standard handle and a tip built of 5 parallel razor blades enclosed by protective cap opened by a separate button. This device will enable to perform shallow slashes on the ovarian cortex following the grasping of the ovary without damaging other abdominal and pelvic organs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of cuts and closeness to blood vessel	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	Up to 30 days after procedure
Secondary	Proximity of cuts to blood vessel	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	Up to 30 days after procedure