Objectives: The aim of this study is assessing the ovarian reserve after laparoscopic cystectomy of endometrioma with and without vasopressin injection.
Setting: This is a not Blind- randomized, controlled, single center trial.
Inclusion criteria are patients in 18 - 40 years old with menstruation and ovarian problems in terms of endometrioma- pelvic problem. Exclusion criteria are previous ovarian surgery or any pelvic adhesion, underlying endocrine disease and history of chemotherapy.
Intervention: Before the surgery the level of Anti-Mullerian Hormone FSH, LH and Estradiol will be measured in all patients. Then patients randomly will be divided in two groups. In control group, cystectomy will be done routinely. In intervention group during cystectomy, 20 units of vasopressin will be injected between cortex and cyst edge in 3 locations and then the cyst will be removed. After 3 months blood factors will be measured again and ovarian reserve will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030126855N1
Registration date:2016-04-06, 1395/01/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-04-06, 1395/01/18
Registrant information
Name
Maryam Razavi
Name of organization / entity
Tehran university of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
mrazavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Science
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
assessment of ovarian reserve after endometrioma laparoscopic cystectomy with and without vasopressin injection
Public title
effect of vasopressin on ovarian reserve after cystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 to 40 years old; with menstruation; with endometrioma; pelvic problems
Exclusion criteria: history of ovarian surgery; pelvic adhesion; underlying endocrine disease; history of chemotherapy
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The sequence of treatment will be written on 64 cards. Cards placed inside the envelopes. Random 10-digit code is written on each envelope. When a qualified patient is announced by the surgeon, the methodologist puts envelope in his possession.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Science
Street address
Tehran University of Medical Science, Keshavarz Boulevard, Qods Street
City
Tehran
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.TUMS.REC.1394.1734
Health conditions studied
1
Description of health condition studied
ovarian reserve
ICD-10 code
S37.4
ICD-10 code description
Injury of ovary
Primary outcomes
1
Description
FSH
Timepoint
before and 3 months after surgery
Method of measurement
ELIZA kit
2
Description
anti mullerian hormone
Timepoint
before and 3 months after surgery
Method of measurement
ELIZA kit
3
Description
LH
Timepoint
before and 3 months after surgery
Method of measurement
ELIZA kit
4
Description
esteradiol
Timepoint
before and 3 months after surgery
Method of measurement
ELIZA kit
Secondary outcomes
empty
Intervention groups
1
Description
Control group : After general anesthesia, cyst is taken by kocher and cut with scissors. Cysts and ovarian cortex between the wall surface is separated.
Category
Treatment - Surgery
2
Description
Intervention group: Cystectomy is done similar to control group. During cystectomy, 20 units of vasopressin will be injected between cortex and cyst edge.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women hospital
Full name of responsible person
Dr.Maryam Razavi
Street address
Arash women hospital, Rashid street, Resalat highway, Tehranpars
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science, research deputy
Full name of responsible person
Dr Masoud Younesian
Street address
Tehran University of Medical Science, Keshavarz boulevard, Qods street,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Science, research deputy
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, Arash women hospital
Full name of responsible person
Maryam Razavi
Position
women specialist
Other areas of specialty/work
Street address
Arash women hospital, Rashid street, Resalat highway,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
mrazavi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Science, Arash women hospital
Full name of responsible person
Maryam Razavi
Position
women specialist
Other areas of specialty/work
Street address
Arash women hospital, Rashid street, Resalat highway,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
mrazavi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arash Women's Hospital, Tehran University of Medical sciences