The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels
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Purpose
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).
| Condition |
|---|
|
Birth Control |
| Study Type: | Observational |
| 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
| Estimated Enrollment: | 159 |
| 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) |
| Groups/Cohorts |
|---|
|
Tubal ligation
Patients who elect to have tubal ligation
|
|
Essure
Group that elects to have Essure placement
|
|
Levonorgestrel IUD
Patients that elect to have a levonorgestrel intra-uterine device placement
|
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 (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.
Eligibility| Ages Eligible for Study: | 25 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Women seeking contraceptive methods seen at Maricopa Integrated Health System, Fertility Centers of Arizona, or St Joseph's Hospital & Medical Center
Inclusion Criteria:
- English-speaking
- Female
- Age 25-40
- Electing one of the following contraceptive methods: tubal ligation, Essure, levonorgestrel IUD
- Ability to understand study procedures and to comply with them for the entire length of the study
- Willingness to comply with follow-up visit requirements
Exclusion Criteria:
- Age <25 or >40 at initiation or completion of the study
- Prior oophorectomy or salpingectomy
- Prior surgery of the ovaries or fallopian tubes
- Prior ovarian, uterine, or fallopian tube cancers
- Prior ovarian, uterine, or fallopian tube radiation exceeding >200rads
- Prior platinum-based or alkalizing chemotherapy
- Current cancer (any form)
- Current pregnancy
- Allergy to any of the components of the selected devices (titanium, rubber, nickel, plastic, silicone)
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of a potential participant to give written informed consent
- Inability for the potential participant to consent for herself
Contacts and Locations| Contact: Daniel F Rychlik, MD | 480-559-0252 | drychlik@sbcglobal.net |
| Contact: Lisa M Cookingham, MD | 602-448-6599 | Lisa.Cookingham@mihs.org |
| United States, Arizona | |
| Maricopa Integrated Health System | Not yet recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Contact: Daniel F Rychlik, MD 480-559-0252 drychlik@sbcglobal.net | |
| Contact: Jessica Huard, MD 602-344-5084 jessica.huard@mihs.org | |
| St Joseph's Hospital & Medical Center | Not yet recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: Daniel F Rychlik, MD 480-559-0252 drychlik@sbcglobal.net | |
| Contact: Lisa M Cookingham, MD 602.448.6599 lisa.cookingham@mihs.org | |
| Fertility Centers of Arizona | Not yet recruiting |
| Scottsdale, Arizona, United States, 85258 | |
| Contact: Daniel F Rychlik, MD 480-559-0252 drychlik@sbcglobal.net | |
| Contact: Lisa M Cookingham, MD 602.448.6599 lisa.cookingham@mihs.org | |
| Principal Investigator: | Daniel F Rychlik, MD | Maricopa Integrated Health System/Fertility Centers of Arizona |
More Information
Publications:
| Responsible Party: | Maricopa Integrated Health System |
| ClinicalTrials.gov Identifier: | NCT01308931 History of Changes |
| Other Study ID Numbers: | 2010-012 |
| Study First Received: | March 2, 2011 |
| Last Updated: | September 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Maricopa Integrated Health System:
|
Contraception IUD Essure Tubal ligation Anti-Mullerian hormone |
Additional relevant MeSH terms:
|
Hormones Levonorgestrel Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents, Female |
Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptives, Oral, Synthetic Contraceptives, Oral |
ClinicalTrials.gov processed this record on May 21, 2013