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

Effect of Vasopressin Injection Technique in Laparoscopic Excision of Unilateral Ovarian Endometriomas on Ovarian Reserve: Prospective Randomized Study

Endometriosis is a common disease with an incidence rate of 15% in women of childbearing age, and is a chronic disease that significantly affects women's quality of life by causing two problems: pain and infertility. 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. Currently, the best way to evaluate ovarian function is to measure AMH (anti-mullerian hormone). However, previous studies has not evaluated ovarian function by AMH. Aim of this study is to compare the anti-mullarian hormone (AMH) change in vasopressin-administered patients after unilateral endometrioma surgery. In this study, antimullerian hormone (AMH) will be used as an indicator of ovarian function evaluation, and will be evaluated before surgery, 6 and 12 months after surgery. Subjects were allocated randomly with stratification of AMH level 3.0mg / ml.

Study Overview

• Status: Unknown
• Conditions: Unilateral Ovarian Endometrioma
• Intervention / Treatment: Procedure: Vasopressin injection

Detailed Description

Endometriosis is a common disease with an incidence rate of 15% in women of childbearing age, and is a chronic disease that significantly affects women's quality of life by causing two problems: pain and infertility. The usual treatment for ovarian endometrioma is surgery, and the most common surgical method is laparoscopy. Surgery has the advantage of reducing the pain of ovarian endometrioma and lower recurrence rate compared to other treatment methods, but it also has the disadvantage of deteriorating ovarian function. 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. Therefore, various surgical methods have been studied to minimize damage to the ovarian tissue during the surgical procedure including local vasopressin injection into the surgical site.

Vasopressin is a peptide hormone secreted by the posterior lobe of the pituitary gland, which promotes reabsorption of water in the kidney when administered systemically, but when administered locally, it constricts blood vessels and prevents bleeding such as in esophageal variceal therapy or myomectomy. There are previous studies that demonstrated, vasopressin injection prior to endometrioma resection, the interface between the endometrioma and normal ovarian tissue is dissected, and the amount of deterioration in ovarian function after surgery is reduced compared to the group without vasopressin by reducing the amount of bleeding through vasoconstriction.

Endometriosis is the most common disease that interferes with pregnancy, and is known to have a significant decrease in ovarian function after surgery compared to other benign ovarian tumors. Currently, the best way to evaluate ovarian function is to measure AMH (anti-mullerian hormone). 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.

Patients who have obtained consent in advance are divided into a test group that injects vasopressin and a control that excises it without injection. In the test group, everything except the administration of vasopressin at the surgical site immediately before the endometriosis was performed is the same as that of the control group. In this study, antimullerian hormone (AMH) will be used as an indicator of ovarian function evaluation, and will be evaluated before surgery, 6 and 12 months after surgery Aim of this study is to compare the anti-mullarian hormone (AMH) change in vasopressin-administered patients after unilateral endometrioma surgery. In this study, subjects were allocated randomly with stratification of AMH level 3.0mg / ml. When α (type 1 error) = 0.05

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Obstetrics and Gynecology, Yonsei University College of Medicine
    • Contact: Sang-Wun Kim, Ph.D; Phone Number: 82-2-2228-2230; Email: san1@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Subjects undergoing laparoscopic ovarian cyst enucleation for unilateral endometrioma.
• 25≤Age≤45
• 0.5≤AMH≤7

Exclusion Criteria:

• Subjects with major medical conditions such as uncontrolled infection, diabetes, severe renal or hepatic disease.
• History of hormonal medication use within 2months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm; During laparoscopic enucleation of unilateral endometrial cyst, no intervention is added to subjects allocated to control arm.
Experimental: Study arm (with vasopressin injection); 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.	Procedure: Vasopressin injection; The intervention consists of five steps: rupture the ovarian endometrial cyst and remove the ''chocolate fluid;'' inject diluted vasopressin solution into the interface between endometrioma and ovarian parenchyma; stop injecting until the solution overflow; separate the endometrioma away from the ovarian parenchyma; and coagulate bleeding spots and suture the ovary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anti-mullerian hormone(AMH)	Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.	before surgery
anti-mullerian hormone(AMH)	Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.	6 months after surgery
anti-mullerian hormone(AMH)	Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation time during surgery	Coagulation time has a relationship with decrease of ovarian function	during surgery

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Saeki A, Matsumoto T, Ikuma K, Tanase Y, Inaba F, Oku H, Kuno A. The vasopressin injection technique for laparoscopic excision of ovarian endometrioma: a technique to reduce the use of coagulation. J Minim Invasive Gynecol. 2010 Mar-Apr;17(2):176-9. doi: 10.1016/j.jmig.2009.11.004.
• Qiong-Zhen R, Ge Y, Deng Y, Qian ZH, Zhu WP. Effect of vasopressin injection technique in laparoscopic excision of bilateral ovarian endometriomas on ovarian reserve: prospective randomized study. J Minim Invasive Gynecol. 2014 Mar-Apr;21(2):266-71. doi: 10.1016/j.jmig.2013.07.024. Epub 2013 Sep 25.
• Zhang NN, Sun TS, Yang Q. An effective "water injection"-assisted method for excision of ovarian endometrioma by laparoscopy. Fertil Steril. 2019 Sep;112(3):608-609. doi: 10.1016/j.fertnstert.2019.05.014. Epub 2019 Jul 4.

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2018
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Endometriosis; Vasopressins; Anti-mullerian Hormone
• Additional Relevant MeSH Terms: Endometriosis; Physiological Effects of Drugs; Natriuretic Agents; Hemostatics; Coagulants; Vasoconstrictor Agents; Antidiuretic Agents; Vasopressins; Arginine Vasopressin
• Other Study ID Numbers: 4-2018-0732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Raw data of basic dermographic informations and outcomes of interventions (AMH, coagulation time, recurrence of endometriosis cyst) can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No