This clinical trial will be performed on hysterectomy candidates admitted to Arash hospital, Tehran, Iran in 2014. After assessing inclusion and exclusion criteria, 40 patients will be included in the study. Patients randomly will be divided into two groups. First group will undergo hysterectomy and salpingectomy. The second group will undergo only hysterectomy. Before intervention and 3 months after it, FSH and anti mullerian hormone levels will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014123118866N4
Registration date:2015-02-15, 1393/11/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-15, 1393/11/26
Registrant information
Name
Afsaneh Tehranian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
afsanehtehranian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of prophylactic salpingectomy on ovarian function in patients undergo hysterectomy by laparascopic & laparatomy in Arash hospital
Public title
Evaluation of prophylactic salpingectomy on ovarian function
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 18-45 years old, candidates for hysterectomy and not oopherectomy; no menopause symptoms; FSH<10 IU.
Exclusion criteria: history of pelvic surgery; existence of ovarian mass in sonography before the surgery; smoking; OCP consumption at least for 6 months.
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
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 Sciences, Keshavarz blvd., Ghods st
City
Tehran
Postal code
Approval date
2015-01-31, 1393/11/11
Ethics committee reference number
9111290009
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
FSH serum level
Timepoint
Before surgery and 3 moths after t
Method of measurement
Blood test
2
Description
Serum anti-mullerian hormone level
Timepoint
Before surgery and 3 months after it
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
First group: the patient undergoes hysterectomy and salpangectomy.
Category
Treatment - Surgery
2
Description
Second group: the patient undergoes only hysterectomy.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women hospital
Full name of responsible person
Dr. Roghieh Hasani
Street address
Arash women hospital, Tehranpars, Resalat highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoudi Yonesian
Street address
Tehran University of Medical Sciences, Keshavarz blvd., Ghods st
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
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 Sciences
Full name of responsible person
Dr. Roghieh Hasani
Position
MD
Other areas of specialty/work
Street address
Arash women hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
somayesaat_hidary@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Afsaneh Tehranian
Position
Specialist of Obstetrics and gynaecology
Other areas of specialty/work
Street address
Arash women hospital, Tehranpars, Resalat highway
City
Tehran
Postal code
Phone
+98 21 7788 3283
Fax
Email
afsanehtehranian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Roghieh Hasani
Position
MD
Other areas of specialty/work
Street address
Arash women hospital
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)