Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

NCT03034616 | Unknown

• 1 other identifier: 029416
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Ovarian Insufficiency

Keywords

Primary ovarian insufficiency; In-vivo activation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proximity of cuts to blood vessel

  Up to 30 days after procedure

Study Arms (3)

ex vivo activation

EXPERIMENTAL

'OLIVA device' in patients that undergo oophorectomy on the cortex of the removed ovary we will perform 5 parallel slashes 3 cm long. this will be followed by investigation by the pathologist as to the depth of cuts.

Device: OLIVA device

in vivo activation

ACTIVE COMPARATOR

'OLIVA device' in patients undergoing oophorectomy before the resection from is pedicle on cortex of the ovary 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.

Device: OLIVA device

POI OLIVA

ACTIVE COMPARATOR

'OLIVA device' in patients with premature ovarian failure and following safety data from arm 2 activation by ovarian slashing will be performed laparoscopically by closed cutting device (OLIVA). follow-up by sonography and hormonal markers of ovarian activity

Device: OLIVA device

Interventions

OLIVA device 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

POI OLIVA; ex vivo activation; in vivo activation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peri/menopausal women undergoing laparoscopic oophorectomy

You may not qualify if:

• Women with ovarian malignancy
• Women with polycystic ovarian syndrome

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: January 27, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share