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Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

This study has suspended participant recruitment.
(It has been put on hold for the moment due to logistic problems)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01723085
First Posted: November 7, 2012
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
OVO R & D
  Purpose

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


Condition
Anti-Mullerian Hormone

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anti-Mullerian Hormone Levels Variations Following an Open Myomectomy

Resource links provided by NLM:


Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Anti-Mullerian Hormone levels variation [ Time Frame: 6 months ]
    Anti-Mullerian Hormone levels before and 6 months after surgery


Biospecimen Retention:   Samples Without DNA
Blood samples collected to measure Anti-Mullerian hormone levels

Estimated Enrollment: 21
Study Start Date: March 2012
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Open myomectomy
All patients belong to the same group Description includes the surgical technique

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women 18 to 42 tears old Indication for myomectomy by laparotomy
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01723085


Locations
Canada, Quebec
Hopital Saint-Luc
Montreal, Quebec, Canada, H2X 3J4
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Eric Himaya, MD Centre hospitalier de l'Université de Montréal (CHUM)
  More Information

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01723085     History of Changes
Other Study ID Numbers: AMH
First Submitted: November 5, 2012
First Posted: November 7, 2012
Last Update Posted: July 25, 2017
Last Verified: July 2017

Keywords provided by OVO R & D:
Anti-Mullerian hormone
Myomectomy
Laparotomy

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs