Does the AMH Concentration Depend on the Menstrual Cycle?

Completed

• Conditions: Reproductive Sterility
• Interventions: Diagnostic Test: menstrual cycle monitoring

• Registration Number: NCT06330259
• Lead Sponsor: University of Basel

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-06-30
• Study Completion: 2019-12-31
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	menstrual cycle monitoring	25 less young women, aged 26 to 39 y.
Group A	menstrual cycle monitoring	25 younger women, aged 18 to 25 y.

Primary Outcome Measures

Name	Time	Method
AMH Elecsys Assay	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 Outcome Measures

Name	Time	Method
3D ultrasound of both ovaries	3 months	Fluctuations in the number of antral follicles during the menstrual cycle.
Effect of handling of the serum on measured AMH concentrations	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

Trial Locations

Locations (1)

Christian De Geyter; 🇨🇭 Basel, Switzerland