This study is a clinical trial to evaluate the level of Antimullerian Hormone Changes in patients with laparoscopic cystectomy of endometrioma with and without vasopressin injection. Sixty six patients with endometrioma that candidate for surgical treatment would be randomly divided into two numerical equal groups. Surgery will be done for one group without vasopressin injection and for the other with vasopressin injection (20 units of vasopressin would be diluted in 200cc of normal saline and then injected in 3 points, each point 3cc, located between ovarian cortex and the cyst wall).
Inclusion criteria: women 20 to 42 years with unilateral endometrioma cyst that candidate for surgical treatment .
Exclusion criteria: history of ovarian surgery; history of chemotherapy; any diagnosed endocrine disease (diabetes) ;medical treatment for endometrioma during last 3 months .
Staging, endometrioma size and location, being environmental or its central, affected ovary and disease stage would be recorded.
Blood sampling would be done for measuring AMH by ELISA before and 6 months after surgery to predict ovarian reserve.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608018897N4
Registration date:2016-11-15, 1395/08/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Safoura Rouholamin
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1236 7001
Email address
s_rouholamin@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Isfahan university of medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of ovarian reserve after laparoscopic cystectomy of endometrioma with and without vasopressin injection
Public title
The effect of vasopressin on ovarian reserve in cystectomy of endometrioma
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women 20 to 42 years with unilateral endometrioma cyst; no medical treatment for endometrioma during last 3 months; Lack of any diagnosed endocrine disease (diabetes, hyperprolactinemia, thyroid disorder); No history of ovarian surgery; No history of chemotherapy.
Exclusion criteria: Lack of consent to participate in the study; any pelvic adhesions that prevent complete removal of the cyst; lack of second AMH measure.
Age
From 20 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib Street
City
Isfahan
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
395171
Health conditions studied
1
Description of health condition studied
endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Anti mullerian hormon
Timepoint
Before surgery and 6 months after surgery
Method of measurement
ELISA
Secondary outcomes
1
Description
HB
Timepoint
Before and 24 hours after surgury
Method of measurement
gr/dl
Intervention groups
1
Description
intervention group:
20 units of vasopressin would be diluted in 200cc of normal saline and then injected in 3 points, each point 3cc, located between ovarian cortex and the cyst wall
Category
Treatment - Drugs
2
Description
control group:
usual laparpscopic cystectomy of endometrioma