Evaluating the AMH Levels During Natural Cycle

February 27, 2018 updated by: Prof Dr. Human Fatemi, ART Fertility Clinics LLC

Anti-Mullerian Hormone Dynamics During Natural Cycle Using Automated Assay

To describe AMH serum levels dynamics during natural cycle using an automated assay.

Study Overview

Status

Completed

Conditions

Detailed Description

The potential benefit would be using an automated assay for AMH, the dynamics of serum levels during the natural cycle and to check the inter-cycle variations.

Because of the many clinical decisions that are based on AMH levels alone the results of this study could bring reassurance to the continuous use of AMH in daily practice. More importantly, no studies to date have been performed on the newer automated assays evaluating variability of AMH levels.

Study Type

Observational

Enrollment (Actual)

20

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

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 37 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Healthy women with regular menstrual cycles.

Description

Inclusion Criteria:

  • Women with written informed consent.
  • Women between ≥ 18 and ≤ 37 years of age.
  • BMI between 18 and 28.
  • Normal physical examination and pelvic exam.

Exclusion Criteria:

  • Pregnancy.
  • Breastfeeding.
  • History of any disease/iatrogenic intervention which could have had an impact on the ovarian reserve (e.g. ovarian surgery, chemotherapy, radiation of the pelvis, endometriosis)
  • Intake of OCP for the two last menstrual cycles.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH serum levels dynamic
Time Frame: 9months

In order to describe each hormone and its dynamics, will determine mean and standard deviations in each time and it will be represented with boxplot figures.

Moreover,the investigator will define polynomial interpolation for dynamic values and each hormone will be represented with mean polynomial interpolation and variance band
9months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-cycle AMH variations
Time Frame: 9months
inter-cycle variability of AMH across two cycles is concluded independently that AMH varies a little between cycles.
9months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Human Fatemi, Medical D., IVI Middle East Fertility Clinic LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 13, 2017

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 6, 2017

First Posted (Actual)

April 10, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1611-ABU-083-HF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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