Ovarian Laparoscopic In Vivo Activation of Ovary for Premature Ovarian Insufficiency

in Vivo Activation of Ovarian Cortex in Premature Ovarian Insufficiency

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03034616

Acronym

OLIVA

Enrollment

Registered

2017-01-27

Start date

2017-01-31

Completion date

2018-06-30

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Ovarian Insufficiency

Keywords

Primary ovarian insufficiency, In-vivo activation

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

Interventions

DEVICEOLIVA 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* Peri/menopausal women undergoing laparoscopic oophorectomy

Exclusion criteria

* Women with ovarian malignancy * Women with polycystic ovarian syndrome

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026