CClinicalTrials.gg
CompletedNCT05297058Updated Oct 28, 2024

Associations of Age Measures With Serum Anti-Müllerian Hormone

An observational study in Aging, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 1 site in Switzerland. Open to female participants aged 35 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Insel Gruppe AG, University Hospital Bern · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
50
Ages
35 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Aging

Keywords

  • Aging
  • Anti-müllerian hormone
  • Bio-functional age
  • Epigenetic age
03

In context

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patients of the Dep. of Obstetrics and Gynecology, Bern University Hospital, Switzerland as well as women contacted by advertisement are eligible for the study.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
50 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Assessing the chronological age

    Evaluated by birthdate of participant

    Time frame: At baseline, once per participant

Secondary outcomes

  1. Serum anti-müllerian hormone (AMH)

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

    Time frame: At baseline, once per participant

  2. Serum follicle-stimulating hormone (FSH)

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

    Time frame: At baseline, once per participant

  3. Serum estradiol (E2)

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

    Time frame: At baseline, once per participant

  4. Subjective age

    Participants will be asked how old they actually feel.

    Time frame: At baseline, once per participant

  5. Externally estimated age

    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.

    Time frame: At baseline, once per participant

  6. Bio-functional age (BFA)

    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.

    Time frame: At baseline, once per participant

  7. Epigenetic age

    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.

    Time frame: At baseline, once per participant

07

Study locations

1 site
  • Dep. of Obstetrics and Gynecology, Bern University Hospital
    Bern, Switzerland
08

References and documents

Publications

  • Stute P, Bitterlich N, Bousquet J, Meissner F, von Wolff M, Poethig D. Measuring Active and Healthy Ageing: Applying a GENERIC Interdisciplinary Assessment Model Incorporating ICF. J Nutr Health Aging. 2017;21(9):1002-1009. doi: 10.1007/s12603-017-0908-1. PubMed 29083441 ↗
  • Stute P, Anker M, Hollenstein L, von Wolff M, Bitterlich N, Meissner F, Poethig D. Measuring chronic stress exposure incorporating the active and healthy ageing (AHA) concept within the cross-sectional Bern cohort study 2014 (BeCS-14). Biopsychosoc Med. 2019 Feb 12;13:2. doi: 10.1186/s13030-019-0143-6. eCollection 2019. PubMed 30805024 ↗
  • Stute P, von Bergen M, Bitterlich N, Meissner F, von Wolff M, Poethig D. Measuring cognitive performance in way that incorporates the concept of active and healthy ageing (AHA). Maturitas. 2019 Jul;125:27-32. doi: 10.1016/j.maturitas.2019.03.018. Epub 2019 Mar 25. PubMed 31133213 ↗
  • Shuster LT, Rhodes DJ, Gostout BS, Grossardt BR, Rocca WA. Premature menopause or early menopause: long-term health consequences. Maturitas. 2010 Feb;65(2):161-6. doi: 10.1016/j.maturitas.2009.08.003. Epub 2009 Sep 5. PubMed 19733988 ↗
  • Hartge P. Genetics of reproductive lifespan. Nat Genet. 2009 Jun;41(6):637-8. doi: 10.1038/ng0609-637. No abstract available. PubMed 19471299 ↗
  • te Velde ER, Pearson PL. The variability of female reproductive ageing. Hum Reprod Update. 2002 Mar-Apr;8(2):141-54. doi: 10.1093/humupd/8.2.141. PubMed 12099629 ↗
  • van Rooij IA, Broekmans FJ, Scheffer GJ, Looman CW, Habbema JD, de Jong FH, Fauser BJ, Themmen AP, te Velde ER. Serum antimullerian hormone levels best reflect the reproductive decline with age in normal women with proven fertility: a longitudinal study. Fertil Steril. 2005 Apr;83(4):979-87. doi: 10.1016/j.fertnstert.2004.11.029. PubMed 15820810 ↗
  • Broer SL, Eijkemans MJ, Scheffer GJ, van Rooij IA, de Vet A, Themmen AP, Laven JS, de Jong FH, Te Velde ER, Fauser BC, Broekmans FJ. Anti-mullerian hormone predicts menopause: a long-term follow-up study in normoovulatory women. J Clin Endocrinol Metab. 2011 Aug;96(8):2532-9. doi: 10.1210/jc.2010-2776. Epub 2011 May 25. PubMed 21613357 ↗
  • Pellatt L, Rice S, Dilaver N, Heshri A, Galea R, Brincat M, Brown K, Simpson ER, Mason HD. Anti-Mullerian hormone reduces follicle sensitivity to follicle-stimulating hormone in human granulosa cells. Fertil Steril. 2011 Nov;96(5):1246-51.e1. doi: 10.1016/j.fertnstert.2011.08.015. Epub 2011 Sep 13. PubMed 21917251 ↗
  • Moolhuijsen LME, Visser JA. Anti-Mullerian Hormone and Ovarian Reserve: Update on Assessing Ovarian Function. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3361-73. doi: 10.1210/clinem/dgaa513. PubMed 32770239 ↗
  • Horvath S. DNA methylation age of human tissues and cell types. Genome Biol. 2013;14(10):R115. doi: 10.1186/gb-2013-14-10-r115. Erratum In: Genome Biol. 2015 May 13;16:96. doi: 10.1186/s13059-015-0649-6. PubMed 24138928 ↗
  • Poloni C, Szyf M, Cheishvili D, Tsoukas CM. Are the Healthy Vulnerable? Cytomegalovirus Seropositivity in Healthy Adults Is Associated With Accelerated Epigenetic Age and Immune Dysregulation. J Infect Dis. 2022 Feb 1;225(3):443-452. doi: 10.1093/infdis/jiab365. PubMed 34255838 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05297058
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Responsible party
Sponsor
First posted
Mar 25, 2022
Start date
Jul 1, 2022
Primary completion
Mar 20, 2024
Completion
Mar 20, 2024
Last update
Oct 28, 2024

Study contacts

Petra Stute, Prof. Dr. med.
study chair · Dep. of Obstetrics and Gynecology, Bern University Hospital, Switzerland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion