The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels
| Status: | Completed |
|---|---|
| Conditions: | Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 25 - 40 |
| Updated: | 5/5/2014 |
| Start Date: | January 2013 |
| End Date: | January 2015 |
| Contact: | Daniel F Rychlik, MD |
| Email: | drychlik@sbcglobal.net |
| Phone: | 480-559-0252 |
The Effect of Tubal Ligation, Essure Placement, AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time
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).
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).
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.
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.
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
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