Evaluation of the effect of vasopressin injection technique in comparison to water injection technique in laparoscopic excision on ovarian reserve after surgery of unilateral ovarian endometrioses in the women with endometriosis that referred to educational hospitals of Shiraz University of Medical Sciences
Determining the effect of vasopressin injection in laparoscopic excision on ovarian reserve after unilateral ovarian endometrioma surgery.
Design
This controlled, parallel-group, randomized, phase 3 clinical trial will be conducted on 60 women diagnosed with endometriosis and unilateral ovarian endometriosis (OMA) (with clinical and ultrasound confirmation by gynecologists). The method of random allocation of permutation blocks is done using Random Allocation software.
Settings and conduct
The researcher will select 60 patients with endometriosis referred to Faqihi Hospital in Shiraz and will randomly divide the permutation blocks into two groups A (vasopressin injection) and B (water injection). Before starting the intervention, ovarian reserve test will be done for all patients under study. Three and six months after surgery, the Anti Mullerian Hormone (AMH) is performed again in both intervention and control groups and compared with the findings of the ovarian reserve test before surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria
18-45-year-old woman with endometriosis with clinical and ultrasound confirmation of endometriosis specialists and unilateral OMA
exclusion criteria
• Patients who had more than one operation due to endometriosis
• Patients with previous history of ovarian surgery
• Patients with previous history of endometriosis surgery
• Patients with AMH < 0.5 or FSH > 10
• History of chemotherapy and radiotherapy
Intervention groups
In group A (intervention), before starting cystectomy, a one-time injection of 5 cc of vasopressin solution is performed in the mesovarium space with a 3.5 x 33.5 aspiration needle in the cyst wall.
In group B (control), normal saline injection is performed before cystectomy
Main outcome variables
Anti Mullerian Hormone (AMH)
AMH level is measured before, three and six months after surgery using ELISA test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240519061837N1
Registration date:2024-07-21, 1403/04/31
Registration timing:prospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Mahboobeh Sattari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3230 5884
Email address
mahboobe.sattari68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of vasopressin injection technique in comparison to water injection technique in laparoscopic excision on ovarian reserve after surgery of unilateral ovarian endometrioses in the women with endometriosis that referred to educational hospitals of Shiraz University of Medical Sciences
Public title
Effect of vasopressin injection technique in laparoscopic excision on ovarian reserve after surgery of unilateral ovarian endometrioses
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-45-year-old woman
Having endometriosis with clinical and ultrasound confirmation by experts
Endometriosis and unilateral OMA with a baseline AMH level between 0.5 and 3
Exclusion criteria:
Patients who had more than one operation due to endometriosis
Patients with previous history of ovarian surgery
Patients with previous history of endometriosis surgery
Patients with AMH < 0.5 or FSH > 10
History of chemotherapy and radiotherapy
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The method of random allocation of replacement blocks will be done using Random Allocation software. In this way, first, various quadruple blocks are created (ABBA, BABA, ABAB, BBAA, AABB, and BABA) and one of these blocks is randomly selected, and according to the order mentioned in the selected block, the patients are divided into one of two groups, A or B. be. Then randomization will be done for other patients as well. In group A (intervention), before the start of cystectomy, a one-time injection of 5 cc of vasopressin solution is performed in the mesovarium space with aspiration needle 33.5 x 3.5 in the cyst wall, and then cystectomy will be performed for them in group B (control) before At the beginning of cystectomy, normal saline injection is performed and then cystectomy will be performed for them.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Street, In front of Palestine Street, Central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.SUMS.MED.REC.1402.359
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
Endometriosis
Primary outcomes
1
Description
Ovarian reserve
Timepoint
Before surgery and three and six months after surgery
Method of measurement
Anti-Müllerian hormone (AMH) serum level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Before starting the cystectomy, a one-time injection of 5cc of vasopressin solution is performed in the mesovarium space with a 3.5x33.5 aspiration needle in the cyst wall, and then cystectomy will be performed for them.
Category
Treatment - Drugs
2
Description
Control group: before starting cystectomy, normal saline injection is done and then cystectomy will be done for them.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faqihi Hospital
Full name of responsible person
Mahboobe Sattari
Street address
Karim Khan Zand Boulevard - next to the medical school
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3235 1087
Email
Faghihi@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempour
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahboobe Sattari
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street,In front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mahboobe.sattari68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahboobe Sattari
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mahboobe.sattari68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahboobe Sattari
Position
Obstetrics and Gynecology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
mahboobe.sattari68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available