The aim of this study is to assess of ovarian reserve of patients with endometrioma after total and partial laparosccopic surgery with ovary cauterization. This is a randomized and single center study. Inclusion criteria are patients aged between 15- 45 years old; with regular menstruation; Caught in terms of ovarian endometrioma and pelvic problems. Exclusion criteria are: history of ovarian surgery and chemotherapy; pelvic adhesion; underlying endocrine disease. number of 72 patients will be entered the study. The blood level of Anti-Mullerian Hormone FSH, LH, Estradiol of all patients will be measured before surgery. Then patients randomly will be divided into two groups. In control group, the total cystectomy will be done and in intervention group cyst will be removed 80% and the remnant will be cauterized with40 watt bipolar Cautery. After 3 months, the level of hormones will be measured again nad ovarian reserve will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016030626698N2
Registration date:2016-03-18, 1394/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Mahroo Rezaeinejad
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
m-rezaeinegad@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of ovarian reserve of patients with endometrioma after total and partial laparosccopic surgery with ovary cauterization
Public title
The effect of total and partial laparosccopic surgery of endometrioma on ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 15- 45 years old; regular menstruation; Caught in terms of ovarian endometrioma; pelvic problems
Exclusion criteria: history of ovarian surgery and chemotherapy; pelvic adhesion; underlying endocrine disease
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.TUMS.REC.1394.1346
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
Ovarian reserve
Timepoint
Before and 3 months after surgery
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: cyst will be removed and the rest will be cauterized by a 40 watt cautery device.
Category
Treatment - Surgery
2
Description
control group: total cystectomy will be done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, research deputy
Full name of responsible person
Dr Masoud Younesian
Street address
Qouds street, Keshavarz boulvard
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 Sciences, 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
Mah rou Rezaee Nejad
Position
women specialist
Other areas of specialty/work
Street address
Arash women hospital, Rashid streert, Resalat highway,Tehranpars
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
m_rezaeenegad@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical ScienceS, Arash women hospital
Full name of responsible person
Mah-rou Rezaee-Nejad
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
m-rezaeenegad@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
Full name of responsible person
Mah-rou Rezaee- Nejad
Position
women specialist
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
m-rezaeenegad@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)