Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128983
Other study ID # Emilia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2015
Est. completion date December 31, 2016

Study information

Verified date November 2018
Source Ava AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Research results suggest changes of physiological parameters such as heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion during the menstrual cycle. Latest fitness trackers allow to conveniently and non-invasively record these parameters. The present study aims to evaluate whether there is a correlation between physiological parameters and the menstrual cycle i.e. ovulation as measured by a urine ovulation test and the onset of menses. To collect data women will wear two smartwatches and a smartshirt at night. All three devices are CE-approved for sports and fitness.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date December 31, 2016
Est. primary completion date December 31, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria:

- Healthy, non-pregnant women aged 20-40 years (healthy volunteers)

- Regular cycling (28 days +/- 2)

- Non-hormonal contraception methods used

- German-speaking

- Written informed consent to participate in the study

Exclusion Criteria:

- Any health-related issues that may affect menstrual cycle

- Any consumption of medication or other substances that may affect the menstrual cycle or any of the physiological parameters investigated

- Frequent travel between time zones

- Sleeping disorders

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation


Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
Ava AG Centre Suisse d’Electronique et de Microtechnique (CSEM), Switzerland, Eidgenössische Materialprüfungs- und Forschungsanstalt (EMPA), Switzerland, University Hospital, Zürich

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation between menstrual cycle dynamics and physiology Correlation between a combination of the physiological parameters heart rate, respiration, skin conductance response, sleep duration, sleep quality and skin perfusion and menstrual cycle dynamics. During 1 menstrual cycle between 24 days and 35 days
See also
  Status Clinical Trial Phase
Withdrawn NCT02759705 - Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Not yet recruiting NCT02534857 - A Study Comparing a Shorter Exposure of Oocyte to Spermatozoa Versus a Standard Incubation on the Live Birth Rate of In-vitro Fertilization Treatment N/A
Enrolling by invitation NCT01803893 - Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome N/A
Completed NCT01888744 - Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist Phase 4
Terminated NCT01173276 - Intrauterine Insemination In HIV-Discordant Couples N/A
Not yet recruiting NCT03680937 - Methods for Fertility Preservation: Impact of Vitrification on in Vitro Matured Oocytes
Completed NCT03455062 - Fertility Study of Women Who Received Organ Transplantation N/A
Completed NCT02736214 - Reproductive Life Plan-based Counseling With Men N/A
Completed NCT01895192 - Sperm Morphology by High Magnification in Fertility Men N/A
Terminated NCT01614704 - Impact of Sequential Chemotherapy on Young Patients Breast Cancer Treated Fertility
Terminated NCT01232972 - Oocyte Cryopreservation N/A
Terminated NCT01268592 - Fertility Preservation in Female Cancer Patients N/A
Completed NCT01012596 - Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
Completed NCT00390754 - Usefulness of Home Pregnancy Testing N/A
Completed NCT00231504 - Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count Phase 1
Completed NCT03345264 - The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study N/A
Recruiting NCT05414812 - Intervening on Women's Health for Rural Young Breast Cancer Survivors N/A
Active, not recruiting NCT02661932 - Fertility Preservation in Breast Cancer Patients Phase 4
Recruiting NCT06172504 - Ejaculation Frequency and Semen Parameters
Recruiting NCT02878434 - Fertility Preservation in Young Women With Cancer