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Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

This study is currently recruiting participants.
Verified November 2012 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01723085
First received: November 5, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  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:

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Anti-Mullerian Hormone levels variation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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: September 2013
Estimated Primary Completion Date: March 2013 (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

Ages Eligible for Study:   18 Years to 42 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01723085

Contacts
Contact: Eric Himaya, MD (514) 890-8000 ehimaya@gmail.com

Locations
Canada, Quebec
Hopital Saint-Luc Recruiting
Montreal, Quebec, Canada, H2X 3J4
Contact: Eric Himaya, MD     (514) 890-8000     ehimaya@gmail.com    
Principal Investigator: Eric Himaya, MD            
Sponsors and Collaborators
OVO R & D
Investigators
Principal Investigator: Eric Himaya, MD Centre Hospitalier de l'Université de Montréal
  More Information

No publications provided

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT01723085     History of Changes
Other Study ID Numbers: AMH
Study First Received: November 5, 2012
Last Updated: November 5, 2012
Health Authority: Canada: Ethics Review Committee

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013