- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723085
Anti-Mullerian Hormone Levels Before and After an Open Myomectomy
July 27, 2018 updated by: Clinique Ovo
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
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
21
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Quebec
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Montreal, Quebec, Canada, H2X 3J4
- Hôpital Saint-Luc
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women 18 to 42 tears old Indication for myomectomy by laparotomy
Description
Inclusion Criteria:
- 18 to 42 years old
- Requiring open myomectomy for any indication
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Open myomectomy
All patients belong to the same group Description includes the surgical technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Mullerian Hormone levels variation
Time Frame: 6 months
|
Anti-Mullerian Hormone levels before and 6 months after surgery
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Himaya, MD, Centre Hospitalier de l'Université de Montréal (CHUM)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
November 5, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 27, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AMH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anti-Mullerian Hormone
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Kanuni Sultan Suleyman Training and Research HospitalCompletedPsoriasis | Ovarian Reserve | Anti Mullerian HormoneTurkey
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Kanuni Sultan Suleyman Training and Research HospitalCompletedCrohn Disease | Anti-Mullerian Hormone Deficiency | Ovary DiseaseTurkey
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Jose Antonio MorenoUniversitat Autonoma de BarcelonaCompletedInfertility, Female | Anti-Mullerian Hormone DeficiencySpain
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Kanuni Sultan Suleyman Training and Research HospitalCompletedPost Partum Hemorrhage | Anti-Mullerian Hormone DeficiencyTurkey
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