Ignite Creation Date:
2024-05-06 @ 2:36 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04372836
Status:
UNKNOWN
Last Update Posted:
2020-05-04
First Post:
2020-04-29
Brief Title:
Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Effect of Vasopressin Injection Technique in Laparoscopic Excision of Unilateral Ovarian Endometriomas on Ovarian Reserve Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 30mg 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 womens 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 30mg ml When α type 1 error 005
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 30mg ml When α type 1 error 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None