Unilateral Ovarian Endometrioma Clinical Trial
Official title:
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.
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
;