Effect of reduction in fat mass measured by body composition after laparoscopic Bariatric surgery on the return of ovarian function in women with morbid obesity and anovulation
The purpose of this study is the assessment of Bariatric surgery effect on the treatment of anovulation in morbid obese women who have anovulation problem. In this study patients with morbid obesity( BMI >35 with a comorbidity or BMI>40 ) ؛ at Age of 15-45 years with anovulation problem who are candidate for Bariatric Laparoscopic surgery because of morbid obesity are selected and patients with Thyroid disease and Pregnancy are excluded. Morbid obese women who come to obesity clinic of Rasoole-e-Akram Hospital are studied; sample size of this study is estimated 60 patients. In this study the effect of bariatric surgical intervention in the treatment of anovulation in morbid obese women in the years 1391-1392 are evaluated. We can assess ovulation or anovulation after surgery by measuring Luteinizing hormone level on third day of menstrual cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203078588N4
Registration date:2012-06-02, 1391/03/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-02, 1391/03/13
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of reduction in fat mass measured by body composition after laparoscopic Bariatric surgery on the return of ovarian function in women with morbid obesity and anovulation
Public title
Effect of reduction in fat mass after laparoscopic obesity on women with ovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:BMI>40 or >35 with a cormobidty؛ Anovulation proved by lab data؛Age of 15-45 years.
Exclusion criteria:Pregnancy؛Thyroid problems.
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:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
45018
Health conditions studied
1
Description of health condition studied
Anovulation in women
ICD-10 code
N97.0
ICD-10 code description
N97.8
Primary outcomes
1
Description
BMI
Timepoint
Three months after intervention
Method of measurement
Weight divided by the square of height in centimeters
2
Description
LH
Timepoint
Three months after intervention
Method of measurement
Using laboratory kits
Secondary outcomes
1
Description
FSH
Timepoint
Three months after Intervention
Method of measurement
Using laboratory kits
2
Description
Fat Mass
Timepoint
Three months after Intervention
Method of measurement
Bio-impedance device
3
Description
Prolactin
Timepoint
Three months after Intervention
Method of measurement
Using laboratory kits
Intervention groups
1
Description
Laparoscopic bariatric surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-e-Akram Hospital
Full name of responsible person
Zeinab Tamannaie
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences.
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
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.
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
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Dr.Zeinab Tamanaie
Position
GP
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
zeinab_tamannaie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences, Minimally Invasive Surgery Research Center.
Full name of responsible person
Dr.Shahla Chaichian
Position
Laparoscopic Fellowship Women's Cancer
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
shahlachaichian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences, Minimally Invasive Surgery Research Center.
Full name of responsible person
Mohadeseh pishgah Roudsari
Position
Expert Stats
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
00
Fax
Email
mo.pishgah@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)