The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Tubal Ligation, Essure Placement, AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time

Conditions
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Birth Control

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tubal ligation<br>Patients who elect to have tubal ligation | |
| Essure<br>Group that elects to have Essure placement | |
| Levonorgestrel IUD<br>Patients that elect to have a levonorgestrel intra-uterine device placement | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum anti-Mullerian hormone levels | 1 blood draw prior to procedure; four more blood draws at 6-month intervals | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, IUD, Essure, Tubal ligation, Anti-Mullerian hormone