Digital Home Ovulation Test One Cycle at Home Study

Completed

• Conditions: Pregnancy; Fertility

• Registration Number: NCT04667845
• Lead Sponsor: SPD Development Company Limited

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-16
• Study Start: 2020-12-22
• Status Verified: 2021-04
• Primary Completion: 2021-04-22
• Study Completion: 2021-04-22
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 125

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device usability	One menstrual cycle, average 28 days	The usability of the digital home ovulation test when used at home by volunteers seeking to conceive scored on a 7 point Likert scale where 1 is the lowest (most negative) score and 7 is the highest (most positive) score.

Trial Locations

Locations (1)

SPD Development Company Ltd; 🇬🇧 Bedford, Bedfordshire, United Kingdom