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

Birth Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01308931
• Other study ID #: 2010-012
• Status: Withdrawn
• Phase: N/A
• First received: March 2, 2011
• Last updated: August 4, 2014
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: August 2014
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Control

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona
United States	St Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Fertility Centers of Arizona	Scottsdale	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Maricopa Integrated Health System	Fertility Centers of Arizona, St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

References & Publications (2)

Goynumer G, Kayabasoglu F, Aydogdu S, Wetherilt L. The effect of tubal sterilization through electrocoagulation on the ovarian reserve. Contraception. 2009 Jul;80(1):90-4. doi: 10.1016/j.contraception.2008.12.012. Epub 2009 Mar 6. — View Citation

van Rooij IA, Broekmans FJ, Scheffer GJ, Looman CW, Habbema JD, de Jong FH, Fauser BJ, Themmen AP, te Velde ER. Serum antimullerian hormone levels best reflect the reproductive decline with age in normal women with proven fertility: a longitudinal study. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum anti-Mullerian hormone levels	1 blood draw prior to procedure; four more blood draws at 6-month intervals	24 months	No