Birth ControlNCT01308931
The Effect of Birth Control Methods on Anti-Mullerian Hormone (AMH) Levels
An observational study of Birth Control, run by Valleywise Health at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Birth Control
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Women seeking contraceptive methods seen at Maricopa Integrated Health System, Fertility Centers of Arizona, or St Joseph's Hospital \& Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Maricopa Integrated Health System
Phoenix, Arizona, 85008
St Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Fertility Centers of Arizona
Scottsdale, Arizona, 85258
About this study
Official title: 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).
Read the 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.
- Conditions
- Birth Control
- Keywords
- Contraception, IUD, Essure, Tubal ligation, Anti-Mullerian hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum anti-Mullerian hormone levels
1 blood draw prior to procedure; four more blood draws at 6-month intervals
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Birth ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fertility Centers of Arizona, St. Joseph's Hospital and Medical Center, Phoenix
- Responsible party
- Sponsor
- Investigators
- Daniel F Rychlik, MD, Principal investigator, Maricopa Integrated Health System/Fertility Centers of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308931
- Sponsor's protocol ID
- 2010-012
- Status last verified
- Aug 2014
- First submitted
- 2 Mar 2011
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15820810Goynumer 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.
PubMed 19501222
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tubal Ligation, Essure Placement, AND Levonorgestrel Intrauterine Device on Serum Anti-Mullerian Hormone Rates Over Time
- ClinicalTrials.gov ID
- NCT01308931
- Acronym / sponsor ID
- 2010-012
- Conditions
- Birth Control
- Keywords
- Contraception, IUD, Essure, Tubal ligation, Anti-Mullerian hormone
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Collaborators
- Fertility Centers of Arizona, St. Joseph's Hospital and Medical Center, Phoenix
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women seeking contraceptive methods seen at Maricopa Integrated Health System, Fertility Centers of Arizona, or St Joseph's Hospital \& Medical Center
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum anti-Mullerian hormone levels
Time frame: 24 months
1 blood draw prior to procedure; four more blood draws at 6-month intervals
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Results publication: PubMed 15820810van 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.
- Results publication: PubMed 19501222Goynumer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel F Rychlik, MD principal investigator
Maricopa Integrated Health System/Fertility Centers of Arizona
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth Control, run by Valleywise Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum anti-Mullerian hormone levels (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308931, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.