Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas

What Was Tested

This registered not phased trial tested Vasopressin for endometriosis.

The usual treatment for ovarian endometrioma is surgery, and the most common surgical method is laparoscopy, however, Surgery has the disadvantage of deteriorating ovarian function.

Previous studies reported that local injection of vasopressin may minimize damage to the ovarian tissue during the surgical procedure.

It had two arms (groups): Control arm (no intervention) and Study arm (with vasopressin injection) (experimental).

During laparoscopic enucleation of unilateral endometrial cyst, no intervention is added to subjects allocated to control arm.

During laparoscopic enucleation of unilateral endometrial cyst, diluted vasopressin is injected into the interface between endometrioma and ovarian parenchyma of patients allocated to study arm.

The registry classes the interventions as procedure.

More on the Plan

The usual treatment for ovarian endometrioma is surgery, and the most common surgical method is laparoscopy.

This is because healthy ovarian tissue adjacent to the ovarian tumor are damaged at the time of surgery, and damage to the ovarian tissue while using an electric cauterizer for hemostasis when removing the ovarian tumor.

In a paper published in JMIG in 2014, the degradation of ovarian function was not evaluated as AMH.

The purpose of this study is to investigate the effect of vasopressin on ovarian function in endometrioma surgery.

Who Took Part

Enrollment: 76 planned participants were the target.

It was open to women only aged from 25 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Subjects undergoing laparoscopic ovarian cyst enucleation for unilateral endometrioma.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: subjects with major medical conditions such as uncontrolled infection, diabetes, severe renal or hepatic disease; history of hormonal medication use within 2months.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Nothing was hidden in this open-label Vasopressin study: the endometriosis participants and staff both knew the treatment.

It started in 2018-10-30 with completion listed for 2020-08.

It ran at 1 site in South Korea.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: anti-mullerian hormone(AMH) (time frame: before surgery). anti-mullerian hormone(AMH) (time frame: 6 months after surgery). anti-mullerian hormone(AMH) (time frame: 12 months after surgery).

It also tracked 1 secondary outcome, for example Coagulation time during surgery.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 76 people with endometriosis.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, Endometriosis research.