Unilateral Ovarian EndometriomaNCT04372836
Vasopressin Injection Technique to Preserve Ovarian Reserve in Surgery for Unilateral Ovarian Endometriomas
A study testing Vasopressin injection in people with Unilateral Ovarian Endometrioma, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Unilateral Ovarian Endometrioma
- What is being tested?
- Vasopressin injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Oct 2018to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Subjects undergoing laparoscopic ovarian cyst enucleation for unilateral endometrioma.
- 25≤Age≤45
- 0.5≤AMH≤7
Who cannot join
- Subjects with major medical conditions such as uncontrolled infection, diabetes, severe renal or hepatic disease.
- History of hormonal medication use within 2months
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Yonsei University College of Medicine
Seoul
Sang-Wun Kim, Ph.D, 82-2-2228-2230, san1@yuhs.ac
About this study
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.
Read the 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
- Being tested
- Vasopressin injection
- Keywords
- Endometriosis, Vasopressins, Anti-mullerian Hormone
- Medical subject headings
- Endometriosis, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control arm | No intervention | During laparoscopic enucleation of unilateral endometrial cyst, no intervention is added to subjects allocated to control arm. |
| Study arm (with vasopressin injection) | Experimental | 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. Receives: Procedure: Vasopressin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Measured: before surgery
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Measured: 6 months after surgery
anti-mullerian hormone(AMH)
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
Measured: 12 months after surgery
Secondary outcomes (1)
Coagulation time during surgery
Coagulation time has a relationship with decrease of ovarian function
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start30 Oct 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unilateral Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372836
- Sponsor's protocol ID
- 4-2018-0732
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw data of basic dermographic informations and outcomes of interventions (AMH, coagulation time, recurrence of endometriosis cyst) can be shared.
Publications
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.
PubMed 20226404Qiong-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.
PubMed 24075865Zhang 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.
PubMed 31280960
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vasopressin Injection Technique in Laparoscopic Excision of Unilateral Ovarian Endometriomas on Ovarian Reserve: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04372836
- Acronym / sponsor ID
- 4-2018-0732
- Conditions
- Unilateral Ovarian Endometrioma
- Keywords
- Endometriosis, Vasopressins, Anti-mullerian Hormone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control arm | No intervention | –During laparoscopic enucleation of unilateral endometrial cyst, no intervention is added to subjects allocated to control arm. |
| Study arm (with vasopressin injection) | Experimental | Procedure: Vasopressin injectionDuring laparoscopic enucleation of unilateral endometrial cyst, diluted vasopressin is injected into the interface between endometrioma and ovarian parenchyma of patients allocated to study arm. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects undergoing laparoscopic ovarian cyst enucleation for unilateral endometrioma.
- 25≤Age≤45
- 0.5≤AMH≤7
Key exclusion criteria (2 listed)
- Subjects with major medical conditions such as uncontrolled infection, diabetes, severe renal or hepatic disease.
- History of hormonal medication use within 2months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vasopressin injectionThe 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. | Procedure or surgery | Study arm (with vasopressin injection) |
Primary outcome
anti-mullerian hormone(AMH)
Time frame: before surgery
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
anti-mullerian hormone(AMH)
Time frame: 6 months after surgery
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
anti-mullerian hormone(AMH)
Time frame: 12 months after surgery
Anti-mullerian hormone is the most reliable marker to assess ovarian reserve to date.
1 secondary outcome
Coagulation time during surgery
Time frame: during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Background: PubMed 20226404Saeki 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.
- Background: PubMed 24075865Qiong-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.
- Background: PubMed 31280960Zhang 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.
- Individual participant dataSharing planned: Undecided. Raw data of basic dermographic informations and outcomes of interventions (AMH, coagulation time, recurrence of endometriosis cyst) can be shared.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vasopressin injection in people with Unilateral Ovarian Endometrioma, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-Wun Kim, Ph.D (82-2-2228-2230, san1@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-mullerian hormone(AMH) (time frame: before surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372836, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.