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

Sponsor

Valleywise Health (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01308931

Collaborator

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

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Birth Control

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jan 1, 2015

Anticipated Study Completion Date :

Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Maricopa Integrated Health System	Phoenix	Arizona	United States	85008
2	St Joseph's Hospital & Medical Center	Phoenix	Arizona	United States	85013
3	Fertility Centers of Arizona	Scottsdale	Arizona	United States	85258