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OpenTrials
Completed

NCT Number: NCT03106272

Evaluating the AMH Levels During Natural Cycle

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

Completed

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Key information

Conditions

Anti-Mullerian Hormone Resistance

Age range

18 year–37 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

Anti-Mullerian Hormone Dynamics During Natural Cycle Using Automated Assay

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Apr 10, 2017
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.