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Associations of Age Measures With Serum Anti-Müllerian Hormone

Completed
Conditions
Aging
Registration Number
NCT05297058
Lead Sponsor
Insel Gruppe AG, University Hospital Bern
Brief Summary

This study aims to assess the association between aging and serum anti-müllerian hormone.

Detailed Description

As life expectancy is increasing and has significant effects on health, economy and other aspects, the need for an Active and Healthy ageing (AHA) strategy becomes more important. Although ageing is often defined by chronological age (CA), it is significantly influenced by other factors such as psychological, social and mental-emotional factors. To evaluate these influences, the bio-functional status (BFS) was created which consists of 45 non-invasive assessments of different categories and reflects a normal middle-European population. By means of BFS the bio-functional age (BFA) can be calculated, revealing individual strengths and resources for healthy ageing as well as potential health risks.

In women ageing leads to a depletion of the ovarian reserves and change of sex hormone levels introducing menopause. Age at menopause is associated with several health issues. Women with premature (age ≤40) or early menopause (age ≤45) are not only considered to have higher risk for osteoporosis but also cardiovascular diseases and cognitive disorders such as dementia. Late menopause (age ≥55) increases the risk of breast and ovarian cancer. Timely preventative measures might limit these risks. For example, hormone replacement therapy has shown to reduce later development of issues associated with premature or early menopause.

The difficulty lies in the variability of age at menopause between 40 and 60 years. In order to take appropriate preventative measures, the age of menopause has to be predicted individually for every woman. This requires a reliable predictive marker for menopause. In studies serum anti-müllerian hormone (AMH) was described as a potential predictor.

AMH is synthetized in granulosa cells of the follicles and reduces the effects of the follicle-stimulating hormone (FSH) on said cells preventing further recruitment of follicles. Hence, AMH is associated with the functional ovarian reserve and declines with age. It is mainly used for detection of reproductive age in women and might be a reliable predictive marker for menopause.

Using the epiAge-test the epigenetic age, also called the biological age, can be calculated. The epiAge-Test was created by Prof. Dr. Moshe Szyf based on the research of Steve Horvath's epigenetic clock. Horvath discovered that DNA methylation can be directly associated with ageing. The methylation occurs on cytosine nucleotides followed by guanine nucleotides creating so called CpG-islands. Taking mathematical and statistical analyses into account, Horvath identified 353 CpG-islands which were consistently altered with age. Szyf further developed Horvath's calculator and created the epiAge-test using 13 CpG-islands that show the highest correlation with ageing to calculate the epigenetic age.

Accordingly, age(ing) can be operationalized in different ways: chronological age (CA) based on birth certificate, subjective age (SA) based on the individual's self-perceived age, externally estimated age (EA) based on the age estimation of two unrelated people, bio-functional age (BFA) based on a 4-dimension validated test-battery, epigenetic age (epiAge) based on DNA methylation increasingly modified with ageing, and serum AMH reflecting a woman's reproductive age.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
50
Inclusion Criteria
  • Informed consent as documented by signature
  • Female
  • Age between 35 and 45 years
  • German as native language
  • Regular menstrual cycle with a mean length of 21-35 days
  • Next menstrual period is predictable within a 7-day time frame
  • Willing to attend bio-functional status analysis and to give blood and saliva samples
Exclusion Criteria
  • Pregnancy or breastfeeding
  • Hormonal contraception
  • Chronic diseases
  • Mental illness
  • Smoking >10 cigarettes per day or over 10 packyears
  • Consumption of >30g alcohol per day (>1 liter of beer or >0.3 liter of wine)
  • Inability to give consent

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Assessing the chronological ageAt baseline, once per participant

Evaluated by birthdate of participant

Secondary Outcome Measures
NameTimeMethod
Serum anti-müllerian hormone (AMH)At baseline, once per participant

A venous blood sample is taken to evaluate the serum AMH level.

Serum follicle-stimulating hormone (FSH)At baseline, once per participant

A venous blood sample is taken to evaluate the serum FSH level.

Serum estradiol (E2)At baseline, once per participant

A venous blood sample is taken to evaluate the serum E2 level.

Subjective ageAt baseline, once per participant

Participants will be asked how old they actually feel.

Externally estimated ageAt baseline, once per participant

Two nurses who don't know the participant or their chronological age will be asked to externally estimate the participant's age. For data analysis, the average of these two estimates will be used.

Bio-functional age (BFA)At baseline, once per participant

To evaluate the bio-functional age, a bio-functional status (BFS) is taken. The BFS consists of 45 separate tests and evaluates physical, physiological, psychomotor, cognitive, mental, and social-emotional factors.

Epigenetic ageAt baseline, once per participant

A saliva sample will be taken to evaluate the epigenetic age. The epigenetic age is evaluated by examining DNA methylation. No genetic data is collected.

Trial Locations

Locations (1)

Dep. of Obstetrics and Gynecology, Bern University Hospital

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Bern, Switzerland

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