NCT06330259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

12 months

First QC Date

March 19, 2024

Last Update Submit

March 28, 2024

Conditions

Reproductive Sterility

Keywords

natural menstrual cycleAMH3D ultrasound

Outcome Measures

Primary Outcomes (1)

  • AMH Elecsys Assay

    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.

    3 months

Secondary Outcomes (2)

  • Effect of handling of the serum on measured AMH concentrations

    3 months

  • 3D ultrasound of both ovaries

    3 months

Study Arms (2)

Group A

25 younger women, aged 18 to 25 y.

Diagnostic Test: menstrual cycle monitoring

Group B

25 less young women, aged 26 to 39 y.

Diagnostic Test: menstrual cycle monitoring

Interventions

menstrual cycle monitoringDIAGNOSTIC_TEST

frequent serum sampling and 3D ultrasound

Group AGroup B

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women are recruited.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

healthy female women with regular menstrual cycles.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christian De Geyter

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Christian De Geyter, MD

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 26, 2024

Study Start

July 1, 2017

Primary Completion

June 30, 2018

Study Completion

December 31, 2019

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)