Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01792362
Status:
COMPLETED
Last Update Posted:
2015-05-06
First Post:
2013-02-13
Brief Title:
Evaluation of Anti-mullerian HormoneAMH Levels as a Predictive Factor of Response to Weight Loss Treatment in Obese Infertile Women With Poly Cystic OvaryPCOS
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Comparing the Basal Anti-mullerian Hormone Levels Between Responders and Non-responders to Weight Loss Diet in Obese Infertile Women With PCOS Population
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a prospective before after clinical trial to compare the basal and 3 months after diet anti-mullerian hormone levels between responders and non-responders to weight loss diet in obese infertile women with PCOS population
Detailed Description:
The study population comprised of all obese infertile PCOS patients aged 20-40 years which underwent 3 months weight loss diet in royan institute Tehran Iran
The study is conducted over 12 wk energy restriction All subjects have the same dietary protocol At baseline week 12 the levels of AMHFollicular Stimulating Hormone FSH Lutienizing HormoneLHProlactin PRL androgens sex hormone-binding globulin SHBG glucose and insulin were measured and Free Androgen Index FAI and Insulin Resistance IR indices is calculated The laboratory tests are determined by radioimmunoassay in the Laboratory of Endocrinology of Royan institute AMH is measured in duplicate using an ultrasensitive ELISA kit AMH-ELIZA Kit Beckman Coulter Marseilles France according to manufacturer instructions All measurements are performed using a single kit and at the same time in the Laboratory of clinical Immunology of Royan institute
Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results Data analysis will be done through descriptive and perceptive statistical methods
The study is conducted over 12 wk energy restriction All subjects have the same dietary protocol At baseline week 12 the levels of AMHFollicular Stimulating Hormone FSH Lutienizing HormoneLHProlactin PRL androgens sex hormone-binding globulin SHBG glucose and insulin were measured and Free Androgen Index FAI and Insulin Resistance IR indices is calculated The laboratory tests are determined by radioimmunoassay in the Laboratory of Endocrinology of Royan institute AMH is measured in duplicate using an ultrasensitive ELISA kit AMH-ELIZA Kit Beckman Coulter Marseilles France according to manufacturer instructions All measurements are performed using a single kit and at the same time in the Laboratory of clinical Immunology of Royan institute
Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results Data analysis will be done through descriptive and perceptive statistical methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None