NCT01308931

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

March 2, 2011

Last Update Submit

August 4, 2014

Conditions

Birth Control

Keywords

ContraceptionIUDEssureTubal ligationAnti-Mullerian hormone

Outcome Measures

Primary Outcomes (1)

  • Serum anti-Mullerian hormone levels

    1 blood draw prior to procedure; four more blood draws at 6-month intervals

    24 months

Study Arms (3)

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

Eligibility Criteria

Age25 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

St Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Fertility Centers of Arizona

Scottsdale, Arizona, 85258, United States

Location

Related Publications (2)

  • 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. Fertil Steril. 2005 Apr;83(4):979-87. doi: 10.1016/j.fertnstert.2004.11.029.

    PMID: 15820810RESULT

  • 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.

    PMID: 19501222RESULT

Study Officials

  • Daniel F Rychlik, MD

    Maricopa Integrated Health System/Fertility Centers of Arizona

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 4, 2011

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

US(3)