Aging Clinical Trial
Official title:
Association of Chronological Age, Subjective Age and Bio-functional Age With Serum Anti-müllerian Hormone
Verified date | November 2023 |
Source | Insel Gruppe AG, University Hospital Bern |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to assess the association between aging and serum anti-müllerian hormone.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Obstetrics and Gynecology, Bern University Hospital | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
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. — View Citation
Hartge P. Genetics of reproductive lifespan. Nat Genet. 2009 Jun;41(6):637-8. doi: 10.1038/ng0609-637. No abstract available. — View Citation
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;16:96. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing the chronological age | Evaluated by birthdate of participant | At baseline, once per participant | |
Secondary | Serum anti-müllerian hormone (AMH) | A venous blood sample is taken to evaluate the serum AMH level. | At baseline, once per participant | |
Secondary | Serum follicle-stimulating hormone (FSH) | A venous blood sample is taken to evaluate the serum FSH level. | At baseline, once per participant | |
Secondary | Serum estradiol (E2) | A venous blood sample is taken to evaluate the serum E2 level. | At baseline, once per participant | |
Secondary | Subjective age | Participants will be asked how old they actually feel. | At baseline, once per participant | |
Secondary | 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. | At baseline, once per participant | |
Secondary | 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. | At baseline, once per participant | |
Secondary | 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. | At baseline, once per participant | |
Secondary | Assessing the correlation between subjective and externally estimated age | At baseline, once per participant | ||
Secondary | Assessing the correlation between BFA and serum AMH | At baseline, once per participant | ||
Secondary | Assessing the correlation between subjective age and BFA | At baseline, once per participant | ||
Secondary | Assessing the correlation between subjective age and serum AMH | At baseline, once per participant | ||
Secondary | Assessing the correlation between externally estimated age and serum AMH | At baseline, once per participant | ||
Secondary | Assessing the correlation between externally estimated age and chronological age | At baseline, once per participant | ||
Secondary | Assessing the correlation between subjective age and chronological age | At baseline, once per participant | ||
Secondary | Assessing the correlation between externally estimated age and BFA | At baseline, once per participant | ||
Secondary | Assessing the correlation between chronological age and serum AMH | At baseline, once per participant | ||
Secondary | Assessing the correlation between epigenetic age and serum AMH | At baseline, once per participant | ||
Secondary | Assessing the correlation between epigenetic age and chronological age | At baseline, once per participant | ||
Secondary | Assessing the correlation between epigenetic age and subjective age | At baseline, once per participant | ||
Secondary | Assessing the correlation between epigenetic age and BFA | At baseline, once per participant | ||
Secondary | Assessing the correlation between epigenetic age and externally estimated age | At baseline, once per participant |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05433233 -
Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension
|
N/A | |
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Completed |
NCT05293730 -
Trial of the Impact of the Electronic Frailty Integrated With Social Needs
|
N/A | |
Recruiting |
NCT03932162 -
Gene Expression Changes In Young and Geriatric Skin
|
Early Phase 1 | |
Completed |
NCT04064528 -
Effects of Age on Amino Acid Delivery to Tendon
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT06029920 -
Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment
|
N/A | |
Recruiting |
NCT05543980 -
Leg Heat Therapy in Elderly Individuals
|
Phase 2 | |
Recruiting |
NCT05566938 -
Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly
|
N/A | |
Completed |
NCT04894929 -
Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement
|
N/A | |
Not yet recruiting |
NCT06071130 -
Emotion, Aging, and Decision Making
|
N/A | |
Enrolling by invitation |
NCT04641663 -
Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST)
|
N/A | |
Completed |
NCT04088006 -
The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity
|
N/A | |
Completed |
NCT03695081 -
Patient Pathway Pharmacist - Optimal Drug-related Care
|
N/A | |
Recruiting |
NCT05424263 -
Acetate and Age-associated Arterial Dysfunction
|
Phase 2 | |
Completed |
NCT05601713 -
Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling
|
N/A | |
Completed |
NCT04551339 -
Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19
|
N/A | |
Recruiting |
NCT04997577 -
Speech Perception and High Cognitive Demand
|
N/A | |
Completed |
NCT05922475 -
Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training
|
N/A | |
Completed |
NCT04015479 -
Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults
|
N/A |