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

Withdrawn

• Conditions: Birth Control

• Registration Number: NCT01308931
• Lead Sponsor: Valleywise Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Study Start: 2013-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum anti-Mullerian hormone levels	24 months	1 blood draw prior to procedure; four more blood draws at 6-month intervals

Trial Locations

Locations (3)

St Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States

Fertility Centers of Arizona; 🇺🇸 Scottsdale, Arizona, United States