Objective: The aim of this study is to determine the effect of salpingectomy on ovarian reserve in women who are candidates for hysterectomy.
Design
Study design: Randomized double-blind clinical trial. Patients will be randomly assigned in two groups, using a random number sequence, generated with a computer software, according to a randomized block design. The randomization list will be created by the clinical trial’s epidemiologist, who keeps the codes until the completion of the study.
Settings and conduct
Among patinets referred to Shabihkhani Clinic affiliated to Kashan University of Medical Sciences, 86 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Premenopausal women aged 30 to 50 years who are undergoing hysterectomy referred to shabihkhani clinic. No menopause symptoms. FSH<10 IU. Exclusion criteria: A history of pelvic surgery, existence of ovarian mass in sonography before the surgery, smoking, OCP consumption at least for 6 months.
Intervention groups
Intervention group: The patients undergo hysterectomy and salpangectomy. Control group: The patients undergo only hysterectomy.
A clinical trial of the effect of salpingectomy on ovarian reserve in women undergoing hysterectomy.
Public title
Effect of salpingectomy in women undergoing hysterectomy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Premenopausal women aged 30 to 50 years who are undergo hysterectomy referred to shabihkhani clinic.
No menopause symptoms
FSH<10 IU.
Exclusion criteria:
A history of pelvic surgery
Existence of ovarian mass in sonography before the surgery
smoking
OCP consumption at least for 6 months.
Age
From 30 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent, patients will be randomly assigned in two groups, using a random number sequence, generated with a computer software, according to a randomized block design. The randomization list will be created by the clinical trial’s epidemiologist, who keeps the codes until the completion of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation concealment will be done by having procedure indicator cards inside a set of numbered opaque sealed envelopes. Patients will be allocated to treatment groups by the author opening the next numbered envelope, after screening, in the presence of the patient. None of the staff or patients will have access to the randomization codes during the study. A patient’s treatment assignment will only be unblended when knowledge of the treatment was essential for the further management of the patient. The surgeon performing the procedures will be blinded to the treatment allocation until the time of surgery.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Approval date
2016-12-07, 1395/09/17
Ethics committee reference number
IR.KAUMS.REC.1395.93
Health conditions studied
1
Description of health condition studied
Uterine bleeding
ICD-10 code
N92.6
ICD-10 code description
Irregular menstruation, unspecified
Primary outcomes
1
Description
Serum anti-mullerian hormone levels
Timepoint
Before surgery and 3 months after intervention
Method of measurement
Elisa kit
Secondary outcomes
1
Description
FSH serum level
Timepoint
Before surgery and 3 months after intervention
Method of measurement
Elisa kit
Intervention groups
1
Description
Intervention group: The patients undergo hysterectomy and salpangectomy.
Category
Treatment - Surgery
2
Description
Control group: The patients undergo only hysterectomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shabihkhani Clinic
Full name of responsible person
Dr. Saba Allamezade Davani
Street address
Shahid Beheshti Avenue, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
Allamezadedavani.s@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamidreza Banafshe
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 4446 0180
Email
Banafsheh.hr@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Dr. Saba Allamezade Davani
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Fax
Email
Allamezadedavani.s@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Saba Allamezade Davani
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Allamezadedavani.s@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Saba Allamezade Davani
Position
Gynecologist
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghotbe Ravandi Boulevard, Kashan
City
Kashan
Province
Isfehan
Postal code
8115187159
Phone
+98 31 5546 3378
Email
Allamezadedavani.s@gmail.com
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