Ignite Creation Date:
2024-05-05 @ 11:20 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01308931
Status:
WITHDRAWN
Last Update Posted:
2014-08-05
First Post:
2011-03-02
Brief Title:
The Effect of Birth Control Methods on Anti-Mullerian Hormone AMH Levels
Sponsor:
Valleywise Health
Organization:
Valleywise Health
Study Overview
Official Title:
The Effect of Tubal Ligation Essure Placement AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time
Status:
WITHDRAWN
Status Verified Date:
2014-08
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:
Anti-mullerian hormone AMH has been shown to be a reliable marker of ovarian reserve In prior studies tubal ligation has been shown to have an adverse effect on ovarian reserve One theory postulated for this effect is that the ovarian circulation is disrupted by the procedure leading to altered hormone production In this prospective cohort study the investigators plan to analyze the rates of AMH decline by comparing the following contraceptive methods tubal ligation Essure placement and levonorgestrel intrauterine devices IUDs
Detailed Description:
Anti-mullerian hormone AMH has been shown to be a reliable marker of ovarian reserve because levels demonstrate a consistent age-related decline and do not fluctuate throughout the menstrual cycle In prior studies measuring markers other than AMH tubal ligation has been shown to have an adverse effect on ovarian reserve
The primary aim of this study will be to compare the rates of anti-mullerian hormone AMH decline following tubal ligation Essure placement and levonorgestrel IUDs and then identifying any and all differences that these specific contraceptive methods have on the changes of AMH rates over time The secondary aim will focus on analyzing the various types of tubal ligation methods ie coagulation ligation clips bands etc to see if different techniques result in any difference in the rate of AMH decline The hypothesis is that tubal ligation will result in an accelerated rate of AMH decline as compared to other long-term or permanent contraceptive methods
The primary aim of this study will be to compare the rates of anti-mullerian hormone AMH decline following tubal ligation Essure placement and levonorgestrel IUDs and then identifying any and all differences that these specific contraceptive methods have on the changes of AMH rates over time The secondary aim will focus on analyzing the various types of tubal ligation methods ie coagulation ligation clips bands etc to see if different techniques result in any difference in the rate of AMH decline The hypothesis is that tubal ligation will result in an accelerated rate of AMH decline as compared to other long-term or permanent contraceptive 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