Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas
Primary Purpose
Unilateral Ovarian Endometrioma
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vasopressin injection
Sponsored by
About this trial
This is an interventional supportive care trial for Unilateral Ovarian Endometrioma focused on measuring Endometriosis, Vasopressins, Anti-mullerian Hormone
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
Sites / Locations
- Department of Obstetrics and Gynecology, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control arm
Study arm (with vasopressin injection)
Arm Description
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.
Outcomes
Primary Outcome Measures
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Secondary Outcome Measures
Coagulation time during surgery
Coagulation time has a relationship with decrease of ovarian function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04372836
Brief Title
Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas
Official Title
Effect of Vasopressin Injection Technique in Laparoscopic Excision of Unilateral Ovarian Endometriomas on Ovarian Reserve: Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2018 (Actual)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Ovarian Endometrioma
Keywords
Endometriosis, Vasopressins, Anti-mullerian Hormone
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Primary and secondary outcomes are compared between study group and control group 6 months and 12 months after intervention during surgery for unilateral endometrioma.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
During laparoscopic enucleation of unilateral endometrial cyst, no intervention is added to subjects allocated to control arm.
Arm Title
Study arm (with vasopressin injection)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vasopressin injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
anti-mullerian hormone(AMH)
Description
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Time Frame
before surgery
Title
anti-mullerian hormone(AMH)
Description
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Time Frame
6 months after surgery
Title
anti-mullerian hormone(AMH)
Description
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Coagulation time during surgery
Description
Coagulation time has a relationship with decrease of ovarian function
Time Frame
during surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Objective of this study is to assess decrease in ovarian reserve after ovarian endometrioma surgery.
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-Wun Kim, Ph.D
Phone
82-2-2228-2230
Email
san1@yuhs.ac
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Yonsei University College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Wun Kim, Ph.D
Phone
82-2-2228-2230
Email
san1@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Raw data of basic dermographic informations and outcomes of interventions (AMH, coagulation time, recurrence of endometriosis cyst) can be shared.
Citations:
PubMed Identifier
20226404
Citation
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.
Results Reference
background
PubMed Identifier
24075865
Citation
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.
Results Reference
background
PubMed Identifier
31280960
Citation
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.
Results Reference
background
Learn more about this trial
Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas
We'll reach out to this number within 24 hrs