Effect of Vasopressin Injection Technique in Laparoscopic Excision of Unilateral Ovarian Endometriomas on Ovarian Reserve
Description
Study Objective: To assess the efficacy of vasopressin injection in reducing anti-Müllerian hormone(AMH) decreases following surgery for unilateral endometrioma. Design: In this randomized controlled study, patients were stratified according to AMH level, then randomly assigned to the vasopressin injection group or control group. AMH level was measured 12 months after laparoscopic surgery (primary endpoint). Analyses for the primary endpoint were performed using an independent t-test, analysis of covariance, and linear mixed model for random and fixed effects. Setting: Tertiary university-affiliated medical center. Patients: Seventy-five women. Interventions: Conservative laparoscopic surgery for unilateral ovarian endometrioma with or without vasopressin injection. Measurements and Main Results: In the intention-to-treat analysis, cyst stripping (14.38±13.68 min vs. 8.91±7.89 min, p=.054) and bleeding control (6.53±6.77 min vs. 2.15±2.53 min, p=.002) times were shorter in women who received vasopressin. However, the decrease of AMH level 12 months after surgery did not differ significantly between the the control and vasopressin groups (-1.17±0.97 ng/mL vs.-0.96±1.11 ng/mL, respectively; p=.426). AMH values did not differ significantly between the 2 groups over time (pgroup × time= .816) or at any time point (baseline, 3, 6, or 12 months). In subgroup analysis according to baseline AMH level (<3 ng/mL and 3-7 ng/mL), hormone values between the control and vasopressin groups did not differ significantly over time (pgroup × time= .923 and .556, respectively) or at each time point. Similar results were obtained in the per-protocol analysis. In the pathological analysis, the thickness and proportions of the excised ovarian tissue showed no significant difference between the groups. Conclusion: Although vasopressin injection did not prevent a decrease in AMH levels after endometrioma surgery, it reduced cyst stripping and bleeding control times. Trial registration: NCT04372836 (https://clinicaltrials.gov/ct2/show/NCT04372836) Date of registration and enrollment of the first subject: October 29, 2018
Files
Steps to reproduce
We conducted a single-blind, 1:1 parallel-arm, randomized controlled study to assess whether injecting vasopressin could reduce ovarian damage during laparoscopic cystectomy for unilateral endometrioma. This trial was registered at clinicaltrials.gov as NCT04372836 (https://clinicaltrials.gov/ct2/show/NCT04372836). The date of registration and enrollment of the first subject was October 29, 2018. Women scheduled to undergo laparoscopic surgery between September 2018 and July 2021 at a tertiary referral hospital (Severance Hospital of Yonsei University, Seoul, South Korea) were enrolled. The eligibility criteria were: age, 19–45 years; AMH level, 0.5–7 ng/mL (11); unilateral endometrioma; regular menstrual cycle, defined as a cycle duration of 28–30 days, in the 6 months before surgery; no previous surgical treatment for endometriosis; no medical treatment for endometriosis (oral contraceptive pills, progestins, or gonadotropin-releasing hormone agonists) in the previous 3 months; and no known major medical disease. The Institutional Review Board approved this trial (4-2018-0732; September 15, 2018), and all patients provided written informed consent before undergoing laparoscopy. All patients had uniloculated or biloculated unilateral endometriomas diagnosed using transvaginal ultrasonography or magnetic resonance imaging (MRI) (12). The endometrioma size was defined as the mean of its maximum diameter and the diameter perpendicular to the maximum diameter in any dimension, as measured using ultrasonography or MRI (13). In biloculated endometriomas, the size was defined as the mean size of each endometrioma.