Table 3

Feedback obtained to implement on stage 2 study

Pilot study—lessons learntFuture study considerations
PDG test strip interpretation
  • 11/22 (50%) of participants reported that at the peak of their cycle when trying to read the results of the PDG test, a faint line remained after testing; making it unclear if the test was negative or positive.

  • Modification of the test strips by the manufacturer.

  • Additional testing to ensure the reliability of strip interpretation.

  • The use of test strip photo logs.

  • Implementation of a process for participants to use when unsure of strip results.

  • Feedback was provided to manufacturers and technical modifications have taken place (personal communication).

Test strips and cervical mucus visuals
  • The quality of the printed examples of test strip and cervical mucus results should have been clearer with additional examples provided.

  • The use of high-quality images or video examples of test strip and cervical mucus results should be provided online for training and for easy reference by the participant at home.

Vaginal ultrasound
  • 13/22 (58%) showed interest in participating in a larger study that would include vaginal ultrasound.

  • The primary reasons for not wanting to undergo a vaginal ultrasound were; the need for additional visits and the anxiety around the procedure.

  • Provision of additional education, emotional support, logistical assistance and adequate financial compensation to cover travel, and parking must be provided.

  • Additional research staff required.

Flexibility in scheduling
  • Greater flexibility and convenience in study visit and blood draw times to better fit into participants’ daily schedules.

  • After hours or weekend clinic visit schedule considered.

  • An alternate provider of blood specimen collection investigated to assess availability on weekends and off hours.

Research staff support
  • 22/22 (100%) felt supported throughout the study by the principal investigator and part-time research staff with nursing and fertility experience. Contact was maintained through two site clinic visits, and/or weekly phone calls or emails.

  • Greater staffing resources to maintain the same frequency of contact with a larger samples size, provide logistical support and to deal with any participant anxiety associated with the additional procedures added to a future study.

Participant diary
  • A paper diary was completed by the participant on a daily basis and was only verified for completeness at the end of the study. The diary format was cramped and had insufficient room in the notes section.

  • The use of an online diary.

Recruitment
  • The local community demonstrated tremendous interest in the study over a very short time period. Through minimal advertising, primarily focused on word of mouth, recruitment was completed ahead of schedule.

  • Minimal data collected on the demographics was minimum of the study population.

  • Community interest in a larger study is present.

  • Recruitment efforts should have a broader approach with efforts made to include different cultural and socioeconomic groups.

  • Additional demographic data should be collected to better describe the population and variations across ethnic groups.