To evaluate the effect of surgery of endometriosis on fertility and it's complications in women with endometriosis
Design
In this study, 64 Women with endometriosis who complained of infertility and referred to Infertility Center of Besat Hospital in Sanandaj for treatment of infertility were included. Women with endometrium greater than 4 cm and aged 18 to 40 years who complained of infertility were included in the study and women with chronic internal diseases that had a definite need to surgery, as well as their infertility had other causes than endometrium were excluded from the study. Endometriosis surgery was performed for patients in the intervention group with an endometrium size of more than 4 cm. Endometriosis surgery was not performed for patients in the control group. Patients randomly selected based on quadruple blocks. In each group 32 women were studied.
Settings and conduct
The study site was Sanandaj city.
Participants/Inclusion and exclusion criteria
Women with endometrium greater than 4 cm and aged 18 to 40 years who complained of infertility were included in the study.Women with chronic internal diseases that had a definite need to surgery, as well as their infertility had other causes than endometrium were excluded from the study.
Intervention groups
Endometriosis surgery was performed for patients in the intervention group with an endometrium size of more than 4 cm. Endometriosis surgery was not performed for patients in the control group.
Main outcome variables
Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130311012789N19
Registration date:2018-06-05, 1397/03/15
Registration timing:registered_while_recruiting
Last update:2018-06-05, 1397/03/15
Update count:0
Registration date
2018-06-05, 1397/03/15
Registrant information
Name
Masoud Rasolabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4654
Email address
rasolabady@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-11-06, 1397/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of surgery of endometriosis on fertility and it's complications in women with endometriosis
Public title
The effect of surgery of endometriosis on fertility in women with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with endometrium more than 4 cm
Age from 18 to 40 years
Infertility
Exclusion criteria:
The presence of chronic internal diseases
The definitive need for surgery
Other causes of infertility
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly selected based on quadruple blocks.
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 Kurdistan University of Medical Sciences
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.MUK.REC.1396/375
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Pregnancy
Timepoint
Three months and six months after the intervention
Method of measurement
Successful pregnancy with healthy fetus based on ultrasound
Secondary outcomes
1
Description
Pregnancy Complications
Timepoint
Three months and six months after the intervention
Method of measurement
Observing complications such as abortion
Intervention groups
1
Description
Intervention group: Endometrioma surgery was performed for patients in the intervention group with an endometrium size of more than 4 cm.
Category
Treatment - Surgery
2
Description
Control group: Endometrioma surgery was not performed for patients in the control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Maryam Ghorbanian
Street address
Keshavarz St.
City
Sanandaj
Province
Kurdistan
Postal code
66186-34683
Phone
+98 87 3328 5910
Email
Ghorbanian68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research of Kurdistan University of Medical Sciences
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
Mozh.zarei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Maryam Ghorbanian
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
Ghorbanian68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fariba Seyedoshohadaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4674
Email
f.seyedoshohadaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Maryam Ghorbanian
Position
Resident of Obstetrics and Gynecology
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Pasdaran St.
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4673
Email
Ghorbanian68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data on the primary outcome (pregnancy) is for sharing.
When the data will become available and for how long
One year after the publication the data will be available.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Meta-analysis is allowed on the data of this study.
From where data/document is obtainable
Dr. Maryam Ghorbanian, Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran , Email: Ghorbanian68@gmail.com
What processes are involved for a request to access data/document
After one year of publishing the article and publishing the results, those who need the data of this study, could apply via email.