Digital Home Ovulation Test One Cycle at Home Study

Swiss Precision Diagnostics (SPD)

Status: Completed

Conditions: Fertility; Pregnancy

Treatments: Device: Home Ovulation Test

Study type: Observational

Funder types: Industry

Identifiers

NCT04667845

PROTOCOL-1200

Details and patient eligibility

About

This study will assess the usability of a Digital Home Ovulation Test when used at home by lay-users seeking to conceive.

Full description

This study will assess the ease of use of a Digital Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a digital home ovulation test used to detect luteinising hormone (LH) and Estrone-3-Glucuronide (E3G) in urine to identify when ovulation is imminent.

A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.

This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.

Enrollment: 125 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• Aged 18 to 45 years
• Seeking to conceive
• Willing to give informed consent and comply with the investigational procedures

Exclusion criteria

• Taking medication, or has known condition which means they should not get pregnant.

• Currently pregnant or breastfeeding

• Used the digital ovulation test within the last six months

• Currently or previously employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath, P&G or affiliates

• Has an immediate* relative currently or previously (within past 5 years) employed by SPD, Abbott, Alere, Unipath or P&G, or affiliates

  *Immediate relatives are defined as parents, children, siblings or partner/spouse

• Is a qualified or trainee healthcare professional (HCP)

• Has professional experience of using dipstick type tests or lateral flow devices

• Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)

• Using infertility medications or hormone replacement medications containing Luteinising Hormone (LH) or Human Chorionic Gonadotrophin (hCG) (e.g. Pregnyl®)

• Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)

• Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings

• Has been diagnosed with polycystic ovarian syndrome (PCOS)

• Has PCOS symptoms e.g. very irregular cycles, hirsutism

• Has abnormal liver or kidney function

• Is taking antibiotics containing tetracycline