In medicine, men are still the dominant gender. As a doctor, who researches and cures, and as a patient, on whom research is carried out. The majority of drugs available on the market are researched on men, which can have dangerous consequences for women. They have different needs than men and should be included in studies for this very reason. However, there is a lot of catching up to do in women-related research and gender-sensitive medicine. The medical technology company VivoSensMedical, which brought OvulaRing to market maturity in 2012, is driving research for women and is focusing its research on the indication areas of women’s health, female chronobiology and autoimmune diseases in women. To this end, the company is conducting various studies with women based on the biomarker core body temperature. The vision is to bring about a paradigm shift in medical diagnostics and to create gender-sensitive, individualized diagnostics for better therapies.
Core body temperature as a biomarker
By researching the core body temperature as a biomarker, VivoSensMedical has developed a unique method for gynecological, endocrinological cycle diagnostics and brought it to market with the Cyclofertilogram and OvulaRing for the user and the physician. Medical studies with a total of 158 fertility patients were conducted at the University Women’s Clinics in Leipzig and Dresden. These provided new medical insights into ovulation and variability of the female cycle (Alexander 2015 / Regidor 2017) based on 470 evaluated cycles. It was found that nearly 70% of women ovulated outside the expected timing (day 14) but still had a healthy biphasic cycle. The new findings demonstrate the variability of cycles and show that each woman has an individual fertility pattern.
The impact of the female cycle on brain structure and menopause
Since 2016, VivoSensMedical has been involved in a clinical study in collaboration with the Max Planck Institute for Human Cognitive and Brain Sciences that explores the influence of the female cycle on brain structure. The research results will show whether and to what extent the brain structure changes during the different cycle phases of menstruation, follicular phase, fertile window with ovulation and luteal phase.
Since 2019, VivoSensMedical has also been conducting research in the field of menopause. The clinical study on the “Influence of progesterone substitution in the luteal phase on resting energy expenditure in the menopausal transition” is being conducted at the University Women’s Hospital Bern.
Core body temperature as an indirect endocrinological biomarker can be applied in gynecology in many areas. Most importantly, it can be used in individual cycle diagnostics with the detection of ovulation day and fertile phase for conception optimization, in the treatment of in vitro fertilization (IVF) in the natural cycle, and further to support safe hormone-free contraception. Current studies are testing whether core body temperature can be used to detect risks during pregnancy, such as impending miscarriage and other pregnancy diseases, at an early stage.
New therapeutic approach for autoimmune diseases
More than 2.5 million people worldwide suffer from multiple sclerosis (MS International Federation), and women are now three times more likely to develop the disease than men (Ärztezeitung online, Oct. 30, 2017). When analyzing core body temperature patterns in autoimmune diseases, there is currently no research in the literature. This is precisely why autoimmune diseases such as multiple sclerosis and rheumatic diseases are among VivoSensMedical’s research priorities. In everyday clinical practice, there is a lack of diagnostic methods for the early detection of disease relapses that enable therapies to be tailored to the individual course of disease in patients with autoimmune diseases. The identification of relapses in autoimmune diseases currently occurs too late, only after disease relapse, and is characterized by an enormous diagnostic effort (e.g. MRI in MS). Every autoimmune disease is accompanied by inflammatory processes that correlate with a change in core body temperature. Under certain circumstances, these processes are reflected in an individual temperature pattern that needs to be identified. Therefore, VivoSensMedical is currently planning a study on “Core body temperature and autoimmune relapses in women of childbearing potential with multiple sclerosis or rheumatic diseases.” It is expected that individual temperature patterns during an autoimmune flare will be identified, allowing better prediction of flare-ups. This will allow therapies to be tailored to individual relapses and disease progression in real-time.
Exploring the female chronobiology
Every human being is characterized by an individual inner clock, which is responsible for the success of drug therapies, among other things. Depending on this internal clock, drugs, for example, are metabolized differently at different times for each patient. However, this aspect is currently hardly taken into account in the drug therapy of patients. Above all, there is a lack of diagnostic methods for determining individual biorhythms. The vision: The more precise administration of drugs according to the biorhythm to increase the success of therapy and reduce side effects, especially in indication areas with a high demand for drugs, such as oncology. VivoSensMedical is therefore currently a partner for the study “Analysis of chronotype and rhythm stability based on core body temperature” in breast cancer patients in collaboration with Heinrich Heine University Düsseldorf.
In a 2017 study (Eckhart et al. 2017) of VivoSensMedical with the Chronomedical Institute of the Goethe University, Frankfurt am Main, the diurnal core body temperature rhythm of women was explored under “real life” conditions for the first time. Since 2019, the clinical study on the “Influence of progesterone substitution in the luteal phase on resting energy expenditure in menopausal transition” (in collaboration work with the Inselspital Bern) is being conducted.
Overview on ViviSensMedical studies
„Körperkerntemperatur und Autoimmunschübe bei Frauen mit Kinderwunsch und Multipler Sklerose oder rheumatischen Erkrankungen“ (in Planung)
„Analyse von Chronotyp und Rhytmusstabilität anhand der Körperkerntemperatur“, in Zusammenarbeit mit der Heinrich Heine Universität Düsseldorf, Prof. Dr. von Gall, Prof. Dr. med. Horst-Werner Korf
„Anwenderbeobachtung zur Körperkerntemperatur und Veränderung des vaginalen ph-Werts im weiblichen Zyklus“, VivoSensMedical GmbH, Prof. Dr. med. Henry Alexander
„Körperkerntemperatur als Biomarker für die Diagnostik der Schwangerschaftsgesundheit“, VivoSensMedical GmbH, Prof. Dr. med. Henry Alexander
„Einfluss einer Progesteronsubstitution in der Lutealphase auf den Ruheenergieverbrauch in der menopausalen Transition“, in Zusammenarbeit mit dem Inselspital Bern, Universitätsklinik für Frauenheilkunde, Prof. Dr. med. Petra Stute
Recent clinical studies
1999-2007 Klinische Studie und Prüfung zur Testung der Wirksamkeit und Verträglichkeit eines telemetrischen Ringpessars zur Bestimmung der Basaltemperatur der Frau, Universitätsfrauenklinik Leipzig, Prof. Dr. med. Henry Alexander
2012-2013 Monozentristische Studie zur wissenschaftlichen Evaluierung circadianer Temperaturmuster im weiblichen Zyklus mit Hilfe des Wechselringsystems OvulaRing, VivoSensMedical GmbH, Prof. Dr. med. Henry Alexander
2012-2017 Dynamics of core body temperature cycles in longterm measurements under real life conditions in women, Chronomedizinisches Institut der Goethe-Universität, Frankfurt am Main, Prof. Dr. med. Horst-Werner Korf
Since 2013 Anwenderstudie mit dem Körperkerntemperaturmesssystem OvulaRing zur Erforschung der Anwendung im Bereich der assistierten Reproduktionsmedizin, TU Dresden, OÄ. Dr. med. Maren Göckenjan-Festag
2013-2018 Kontinuierliche Körperkerntemperaturmessung als Ergänzung des Zyklusmonitoring bei Patientinnen mit Kinderwunsch. Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe Dresden, OÄ Dr. med. Maren Göckenjan
Seit 2016 Klinische Studie zum Einfluss des Zyklus auf die Hirnstruktur, Max-Planck-Institut für Kognitions- und Neurowissenschaften, Dr. Julia Sacher
Alexander H. 2015. Das Cyclofertilogramm zur exakten Zyklus- und Fertilitätsdiagnostik. In: Ärzteblatt Sachsen; 12: 539-542.
Ekhart D et al. 2017. Dynamics of core body temperature cycles in longterm measurements under real life conditions in women, Chronobiology International, DOI: 10.1080/07420528.2017.1375942
Müller T. 2017. MS-Prävalenz steigt weltweit – liegt es an der Ernährung? Ärztezeitung online. https://www.aerztezeitung.de/medizin/krankheiten/neuro-psychiatrische_krankheiten/multiple_sklerose/article/946497/ms-tagung-ms-praevalenz-steigt-weltweit-liegt-ernaehrung.html Zugriff: 9.7.2019
MS International Federation.