Evaluation of Ovarian Reservation in Women with Endometriosis under Total Cystectomy compared to Partial Cystectomy
Design
A randomized, double-blind, clinical trial with two parallel intervention groups design of 56 patients (phase 3). The table of random numbers was used for randomization.
Settings and conduct
The subjects were selected from among patients with ovarian endometriosis referred to Shahid Sadoughi Hospital in Yazd according to the criteria for entering the study. The diameter of the cyst is measured using vaginal ultrasound or MRI, and in cases of bilateral endometriosis, the total size of the two cysts is considered. Patients will be divided into two groups and randomly divided into two groups using the table of random numbers. One group underwent total cystectomy and the other group underwent partial cystectomy. The amount of anti-mullerian hormone in both groups is measured by ELISA before and 3 months after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age between 20 and 40 years
2- Serum level of anti-Müllerian hormone (AMH) over than 1 ng/mL
3- Endometrioma cyst larger than 4 cm
ٍExclusion criteria:
1- Pregnancy
2- Menstrual bleeding disorder
3- Endocrine disorders include thyroid disorder, hyperprolactinemia, or Cushing's syndrome
4- History of ovarian surgery and surgeries that have altered the anatomy of the pelvic cavity
5- Serum level of follicle stimulating hormone (FSH) level around menopause
6- Suspicion of ovarian malignancies
7- Take oral contraceptive pills (OCPs) three months before surgery
Intervention groups
Intervention group I: under total cystectomy
Intervention group II: under partial cystectomy
Main outcome variables
The serum level hormone anti-müllerian hormone
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200408046993N2
Registration date:2020-05-26, 1399/03/06
Registration timing:retrospective
Last update:2020-05-26, 1399/03/06
Update count:0
Registration date
2020-05-26, 1399/03/06
Registrant information
Name
Atiyeh Javaheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3183 4284
Email address
a.javaheri@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-14, 1398/10/24
Expected recruitment end date
2020-02-13, 1398/11/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Ovarian Reservation in Women with Endometriosis under Total Cystectomy Compared to Partial Cystectomy
Public title
The effect of total cystectomy surgery versus parietal cystectomy on the ovarian reservation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 to 40 years old
Serum level of anti-Müllerian hormone (AMH) over than 1 ng/mL
ٍEndometrioma cyst larger than 4 cm
Exclusion criteria:
Pregnancy
Menstrual bleeding disorder
Endocrine disorders include thyroid disorder, hyperprolactinemia, or Cushing's syndrome
History of ovarian surgery and surgeries that have altered the anatomy of the pelvic cavity
The serum level of follicle stimulating hormone (FSH) around menopause
Suspicion of ovarian malignancies
Take oral contraceptive pills (OCPs) three months before surgery
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in people before surgery, the concentration of antimullerin hormone is measured by ELISA method and after grouping endometriosis in them, by using simple randomization method with individual unit and by using the table of random numbers of people in The two groups of partial and total cystectomy are operated on, and all patients are operated on by one surgeon to minimize the difference in surgical technique.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
School of Medicine, Shahid Sadoughi University of Medical Sciences, Shohaday-e-Gomnam Blvd., Alem Sq., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۱۷۳۱۴۳
Approval date
2020-01-14, 1398/10/24
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.296
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
The serum level of anti-müllerian hormone
Timepoint
At the beginning of the study (Before intervention) and 3 months after the intervention (Cystectomy)
Method of measurement
Eliza's method
2
Description
The serum CA125 level
Timepoint
At the beginning of the study (Before intervention)
Method of measurement
Eliza's method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In this group, total cystectomy surgery was performed in which patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and lithotomy, and carbon dioxide gas was opened by a 10 mm trocar with open method And 10 mm Hg pressure and under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port and 2 other 5 mm ports created 2 cm above the iliac bone and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released, and then the internal wall of the cyst was gently separated from the normal ovarian cortex by two atromatic pliers. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation.
Category
Treatment - Surgery
2
Description
Intervention group 2: In this group, partial cystectomy surgery was performed. In this method, patients underwent general anesthesia and endotracheal intubation in 30 degree Thunderrenberg condition and in lithotomy status, and carbon dioxide gas by a 10 mm trocar with open method and pressure 10 mmHg under the supervision of a 10 mm rigid laparoscope inserted through the umbilical port, two other 5 mm ports created 2 cm above the iliac bone, and a uterine manipulator placed inside the patient's uterus. If necessary, the Keldosak area was released, then the cyst was aspirated and emptied, and the adhesion between the cyst and the pelvic wall was released. The umbilical cord remains the ovary. In all patients, the presence of endometriosis was confirmed by pathology, and the antimullerin levels of the hormone were examined before and 3 months after the operation.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Shahid Sadoghi Hospital
Full name of responsible person
Atiyeh Javaheri
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Fax
+98 35 3822 4100
Email
a.javaheri@ssu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Bahonar Sq., Shahid Sadoughi Ave., Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2136
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Atiyeh Javaheri
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
a.javaheri@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atiyeh Javaheri
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
a.javaheri@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Atiyeh Javaheri
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Shahid Sadoughi hospital, Ebne- Sina Ave., Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 4000
Email
a.javaheri@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available