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

August 4, 2014 updated by: Valleywise Health

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

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 Overview

Status

Withdrawn

Conditions

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System
      • Phoenix, Arizona, United States, 85013
        • St Joseph's Hospital & Medical Center
      • Scottsdale, Arizona, United States, 85258
        • Fertility Centers of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women seeking contraceptive methods seen at Maricopa Integrated Health System, Fertility Centers of Arizona, or St Joseph's Hospital & Medical Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valleywise Health

Collaborators

St. Joseph's Hospital and Medical Center, Phoenix
Fertility Centers of Arizona

Investigators

  • Principal Investigator: Daniel F Rychlik, MD, Maricopa Integrated Health System/Fertility Centers of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 4, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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