The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels
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).
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Effect of Tubal Ligation, Essure Placement, AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time|
- Serum anti-Mullerian hormone levels [ Time Frame: 24 months ] [ Designated as safety issue: No ]1 blood draw prior to procedure; four more blood draws at 6-month intervals
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Patients who elect to have tubal ligation
Group that elects to have Essure placement
Patients that elect to have a levonorgestrel intra-uterine device placement
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 (i.e. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308931
|United States, Arizona|
|Maricopa Integrated Health System|
|Phoenix, Arizona, United States, 85008|
|St Joseph's Hospital & Medical Center|
|Phoenix, Arizona, United States, 85013|
|Fertility Centers of Arizona|
|Scottsdale, Arizona, United States, 85258|
|Principal Investigator:||Daniel F Rychlik, MD||Maricopa Integrated Health System/Fertility Centers of Arizona|