Anti-Mullerian HormoneNCT01723085
Anti-Mullerian Hormone Levels Before and After an Open Myomectomy
An observational study of Anti-Mullerian Hormone, run by Clinique Ovo at 1 site in Canada.
Trial summary
Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Anti-Mullerian Hormone
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Dec 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 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Women 18 to 42 tears old Indication for myomectomy by laparotomy
Who may be able to join
- 18 to 42 years old
- Requiring open myomectomy for any indication
Who cannot join
- Incapable of informed consent
- Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3 months
- Woman over 42 years old
- Post-menopause women
- Positive B-human chorionic gonadotropin the day of surgery
- Ovarian surgery (at the same time)
- Pre-operative AMH below 0.3 ng/mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Anti-Mullerian Hormone Levels Variations Following an Open Myomectomy
Anti-Mullerian hormone (AMH) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy.
Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels in a few months
- Conditions
- Anti-Mullerian Hormone
- Keywords
- Anti-Mullerian hormone, Myomectomy, Laparotomy
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 |
|---|---|---|
| Open myomectomy | All patients belong to the same group Description includes the surgical technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-Mullerian Hormone levels variation
Anti-Mullerian Hormone levels before and 6 months after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: It has been put on hold for the moment due to logistic problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti-Mullerian HormoneStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Himaya, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723085
- Sponsor's protocol ID
- AMH
- Status last verified
- Jul 2018
- First submitted
- 5 Nov 2012
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Mullerian Hormone Levels Variations Following an Open Myomectomy
- ClinicalTrials.gov ID
- NCT01723085
- Acronym / sponsor ID
- AMH
- Conditions
- Anti-Mullerian Hormone
- Keywords
- Anti-Mullerian hormone, Myomectomy, Laparotomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It has been put on hold for the moment due to logistic problems
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Nov 2012 (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) is a marker for ovarian reserve. It is well known that ovarian surgery for endometriosis lowers Anti-Mullerian hormone, but little is known for other surgeries. We seek to investigate the hormone variations before and after an open myomectomy.
Hypothesis: Anti-Mullerian hormone levels drop following surgery but return to normal levels in a few months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open myomectomy | – | –All patients belong to the same group Description includes the surgical technique |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women 18 to 42 tears old Indication for myomectomy by laparotomy
Key inclusion criteria (2 listed)
- 18 to 42 years old
- Requiring open myomectomy for any indication
Key exclusion criteria (7 listed)
- Incapable of informed consent
- Use of hormonal contraception or Gonadotropin-releasing hormone agonists in the past 3 months
- Woman over 42 years old
- Post-menopause women
- Positive B-human chorionic gonadotropin the day of surgery
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
Anti-Mullerian Hormone levels variation
Time frame: 6 months
Anti-Mullerian Hormone levels before and 6 months after surgery
Results and safety
The study was stopped early (reason given: It has been put on hold for the moment due to logistic problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2018.
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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.
Eric Himaya, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti-Mullerian Hormone, run by Clinique Ovo at 1 site in Canada.
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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 stopped early (reason given: It has been put on hold for the moment due to logistic problems). Results are not available in the source record.
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?
Anti-Mullerian Hormone levels variation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2018.