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

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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01308931

Enrollment

Registered

2011-03-04

Start date

2013-01-31

Completion date

2015-01-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Control

Keywords

Contraception, IUD, Essure, Tubal ligation, Anti-Mullerian hormone

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 40 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results