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

NCT ID: NCT04372836

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-30
• Study Completion Date: 2021-08-31

Brief Summary

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.

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

Conditions

Unilateral Ovarian Endometrioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Vasopressin injection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Obstetrics and Gynecology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang-Wun Kim, Ph.D

Role: CONTACT

san1@yuhs.ac

82-2-2228-2230

Facility Contacts

Sang-Wun Kim, Ph.D

Role: primary

san1@yuhs.ac

82-2-2228-2230

References

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.

Reference Type: BACKGROUND

PMID: 20226404 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24075865 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31280960 (View on PubMed)

Other Identifiers

4-2018-0732

Identifier Type: -

Identifier Source: org_study_id