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

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)

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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