10% women

Approx. 10% of all women worldwide have an unfulfilled desire for children

source: Eurostat United Census Bureau

70% women

70% are using contraception. 16 billion USD market for contraceptives in 2013.

source: PR News Wire

Research Status

Determining body core temperature as a biomarker has allowed us to develop a unique gynecological and endocrinological method for menstrual diagnostics, which we have launched onto the market as OvulaRing.

We have worked together with the gynecological departments at the universities of Leipzig and Dresden in conducting medical studies on a total of 158 infertility patients. Our studies have provided new medical findings on ovulation and variation in the menstrual cycle (Alexander 2015/Regidor 2017) from the 470 menstrual cycles evaluated.

We found that almost 70% of women ovulated outside the expected time window (day 14) despite a healthy biphasic pattern. The new findings have demonstrated the variability in menstrual cycles, and that every woman is unique in her fertility pattern.

Core body temperature serves as an indirect endocrinological biomarker in a variety of application areas in gynecology. These especially include diagnostics in an individual menstrual cycle by identifying the day of ovulation and fertile phase toward optimizing conception, treatment during in-vitro fertilization, and support for safe hormone-free contraception. Current studies are currently examining whether core body temperature might also contribute to determining risks such as miscarriage and other pregnancy disorders during early pregnancy.

Projects

2012-2014 Development of innovative diagnostic technologies in reproductive medicine and women’s health

Partner: inotec FuE GmbH / Datenspiel GmbH / TRM Universität Leipzig
Financing: Sächsische Aufbaubank (SAB)

2014 CGB7 as a new diagnostic marker for implantation readiness of the endometrium 

Partner: University of Leipzig, Dr. Sindy Sohr
Financing: Sächsische Aufbaubank (SAB)

Studies:

1999-2007 Clinical study and testing the efficacy and safety of telemetric pessaries in determining basal body temperature in women / University of Leipzig / Prof. Dr. Henry Alexander

2012-2013 Monocentric study on scientific evaluation of circadian temperature patterns during the menstrual cycle using the replaceable OvulaSens pessary system / VivoSensMedical GmbH / Prof. Dr. Henry Alexander

Since 2013 Ongoing user study on core body temperature measurement with the OvulaRing system in researching application in assisted reproductive technology / Technical University of Dresden / Dr. Maren Göckenjan

Since 2016: Clinical study In-vivo dynamics of the human hippocampus across the menstrual cycle / Max-Planck-Institute for human cognitive and brain science / Dr. Julia Sacher

In planning: Clinical study on the influence of progesterone substitution in the luteal phase on the rest energy consumption in menopausal transition / Inselspital Bern, University hospital for women’s health / Prof. Dr. med. Petra Stute, leading doctor and deputy head of the department for gynecological endocrinology and reproductive medicine

Product

OvulaRing

OvulaRing is our first medical diagnostic innovation to fight unfulfilled desires for children-for more rapid recognition of possible menstrual cycle disorders and individual treatment decisions.

OvulaRing provides a novel method for accurate endocrine cycle diagnostics based on continuous body core temperature measurement. OvulaRing is the first that is able to map the entire cycle for exact and complete cycle diagnostics and is therefore ideal for diagnosing fertility issues.

OvulaRing is an approved medical device consisting of a vaginal biosensor and web-based evaluation software. The sensor is worn as a pessary and is unnoticeable to the user. The device continuously measures and stores core body temperature every five minutes at a total of 288 times each day. A reading device transfers the data to mobile software for evaluation using medical algorithms, with results presented in what is referred to as a cyclofertilogram. The algorithms detect individual temperature and fertility patterns, yielding reliable health information on the individual menstrual cycle. This information helps determining the length of the cycle and each cycle phase, window of fertility and time of ovulation, and current probability of conception. Apart from that, the system is able to early detect hormonal cycle disorders, such as anovulation and luteal insufficiency, for more effective treatments.

  • Patent-protected, CE certified medical device class IIa
  • Continuous body-core temperature measurements with 288 measuring points daily
  • Validated and proven in three medical studies with a total of 470 cycles
  • > 10.000 recorded cycles
  • Precise ovulation determination (reliability >99%), ovulation prognosis (reliability 89%) and evaluation of the daily conception probability
  • Enables remote patient monitoring, tele-medical diagnostics and individualized treatments of hormonal cycle disorders
  • Suitable for all cycle types and life-styles
  • Free of hormones and plasticizers
OvulaRing

Individual diagnostics for better therapies

Patents

OUR PATENTS: Promoting innovation, protecting ideas

Our portfolio includes eight international patents and intellectual property rights; we are working hard on new projects and expanding our portfolio.

OvulaRing patents
OvulationDetermination
DE000010345282B3
granted
OvulationDetermination
DE000019943456B4
granted
Flexibel Ring Pessary
EP 2567680A
granted
Flexibel Ring Pessary
US13/606,255
granted
OvulationDetermination
GB1317149.1
examination
Registered design
Flexibel Ring Pessary
GGM Urkunde 001327274-0001
granted
Flexibel Ring Pessary
GGM Urkunde 002016444-0001
granted
Flexibel Ring Pessary
US 29/431,437
granted
Publication

Das Cyclofertilogramm zur exakten Zyklus- und Fertilitätsdiagnostik.

Alexander H 2015. In: Ärzteblatt Sachsen; 12: 539-542.

Identification and prediction of the fertile window with a new web-based medical device using a vaginal biosensor for measuring the circadian and circamensual core body temperature.

Regidor P-A et al. 2017. In: Gynecological Endocrinology, DOI:10.1080/09513590.2017.1390737