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

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

    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Hôpital Saint-Luc

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
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

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

3
Subscribe