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Anti-Mullerian Hormone Levels Before and After an Open Myomectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by OVO R & D
Sponsor:
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT01723085
First received: November 5, 2012
Last updated: June 21, 2013
Last verified: June 2013
  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 ] [ 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 2014
Estimated Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 21, 2013
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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014