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

This study is not yet open for participant recruitment.
Verified September 2012 by Maricopa Integrated Health System
Sponsor:
Collaborators:
Fertility Centers of Arizona
St. Joseph's Hospital and Medical Center, Phoenix
Information provided by (Responsible Party):
Maricopa Integrated Health System
ClinicalTrials.gov Identifier:
NCT01308931
First received: March 2, 2011
Last updated: September 7, 2012
Last verified: September 2012
  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

Resource links provided by NLM:


Further study details as provided by Maricopa Integrated Health System:

Primary Outcome Measures:
  • 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
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308931

Contacts
Contact: Daniel F Rychlik, MD 480-559-0252 drychlik@sbcglobal.net
Contact: Lisa M Cookingham, MD 602-448-6599 Lisa.Cookingham@mihs.org

Locations
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   
Sponsors and Collaborators
Maricopa Integrated Health System
Fertility Centers of Arizona
St. Joseph's Hospital and Medical Center, Phoenix
Investigators
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 April 14, 2014