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OpenTrials
Completed

NCT Number: NCT06330259

Does the AMH Concentration Depend on the Menstrual Cycle?

During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH (anti-Muellerian Hormone) will be measured in the serum.

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Key information

Conditions

Reproductive Sterility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Observational

Primary location

Christian De Geyter

Basel, 4031, Switzerland

About this study

During two none subsequent natural menstrual cycles healthy female participants will be subjected every second day to blood sampling and 3D-ultrasound examinations. Together with four other key hormones the concentration of AMH will be measured in the serum. Half of the serum samples will immediately be subjected to hormone analysis whereas the other half will be stored frozen at -80 °C. After conclusion of the study the frozen samples will be subjected to re-measurment again a reference laboratory. The aim is to study the stability of the AMH Elecsys Assay under both conditions. The participants will be health women aged between 18 and 40 years. They will be grouped into a younger and an older group. They will be observed during one menstrual cycle, then they will remain unobserved during a second menstrual cycle, and then again they will be observed during a third menstrual cycle.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • regular menstrual cycles, between 24 and 32 d.
  • body mass index between 24 and 32 kg/m2
  • no HIV, no Hepatitis B and C
  • no smoking

Exclusion criteria

  • intake of reproductive hormones, including birth control pill
  • pregnancy or breastfeeding
  • infertility
  • polycystic ovary syndrome

Treatment and study plan

menstrual cycle monitoring

Diagnostic Test

frequent serum sampling and 3D ultrasound

Primary outcomes

  1. AMH Elecsys Assay

    Time frame: 3 months

    The anti-Muellerian Hormone (AMH) is a heterodimer. As such, it is unstable. The newly developed assay is considered to account for this inherent instability of the hormone and is thought to produce more consistent results.

Secondary outcomes

  1. Effect of handling of the serum on measured AMH concentrations

    Time frame: 3 months

    Handling of the serum samples may impact measured levels. The serum levels will be measured as part of daily routine both on the day of the sampling and in frozen samples (in batches, under maximal care conditions) the stability of observed serum values during the menstrual cycle

  2. 3D ultrasound of both ovaries

    Time frame: 3 months

    Fluctuations in the number of antral follicles during the menstrual cycle.

Sponsors and collaborators

Lead sponsor

University of Basel

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

Ist Die Konzentration Des Anti-Müllerschen Hormons (AMH) abhängig Vom Menstruationszyklus?

Acronym: AMH

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 26, 2024
Registry last updated
Apr 1, 2024

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.

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