Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency (OLIVA)

H

Hadassah Medical Center

Status

Unknown

Conditions

Primary Ovarian Insufficiency

Treatments

Device: OLIVA device

Study type

Interventional

Funder types

Other

Identifiers

NCT03034616
029416

Details and patient eligibility

About

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.

Full description

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

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion criteria

  • Women with ovarian malignancy
  • Women with polycystic ovarian syndrome

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 3 patient groups

ex vivo activation
Experimental group
Description:
'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.
Treatment:
Device: OLIVA device
in vivo activation
Active Comparator group
Description:
'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.
Treatment:
Device: OLIVA device
POI OLIVA
Active Comparator group
Description:
'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
Treatment:
Device: OLIVA device

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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