Digital Home Ovulation Test One Cycle at Home Study

NCT04667845 | Completed

• 1 other identifier: PROTOCOL-1200
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy; Fertility

Keywords

Trying to Conceive; Digital Home Ovulation Test; Usability

Outcome Measures

Primary Outcomes (1)

• Device usability

  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.

  One menstrual cycle, average 28 days

Interventions

Home Ovulation Test DEVICE

Digital read home ovulation test

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women seeking to conceive

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Study Officials

• Sarah Johnson

  SPD Development Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: December 22, 2020
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)