CClinicalTrials.gg
Status unknownNCT05103982Updated Feb 1, 2022

Testing a New Self-help Intervention for Infertility Related Distress: a Pilot Study

A Phase 1/2 interventional study of Coping with Infertility Program in Infertility, Female, sponsored by University of Regina. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2022-02-01.

Sponsored by University of Regina · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 42 Years
Sex
Female
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Study summary

This pilot study will test the effect of a 6-week self-help program in improving fertility-related quality of life as well as anxious and depressive symptoms, in women with infertility.

Read the detailed description

Twenty women with infertility living in Saskatchewan will be recruited and will be emailed six weekly 10-minute videos, each providing instructions on a new psychological technique that is aimed at addressing the emotional and interpersonal challenges of infertility. Fertility-related quality of life, depressive symptoms, and anxious symptoms will be measured before and after the program. Outcomes will also be measured weekly for three weeks post-intervention. Feedback about how to improve the program will also be collected.

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Conditions studied

  • Infertility, Female

Keywords

  • infertility-related distress
  • depression
  • anxiety
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 20 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University of Regina is the lead sponsor of 56 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Has been trying to get pregnant for 12+ months and has failed OR is currently undergoing fertility treatments due to a diagnosis of infertility
  • Lives in Saskatchewan, Canada
  • Reports a high level of distress related to infertility, as indicated by a FertiQoL score below 52 or at least mild anxious or depressive symptoms (GAD-7 score of 5 or above or PHQ-9 score of 5 or above)

Exclusion criteria

Exclusion Criteria:

  • Has a history of suicide attempts
  • Is currently experiencing suicidal ideation
  • Reports severe depressive symptoms, as indicated by a PHQ-9 score above 19
  • Reports severe anxious symptoms, as indicated by a GAD-7 score above 14
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Coping with Infertility Program

    The program consists of brief weekly videos, each addressing a particular psychological technique to be implemented that week. Participants receive the videos by email from the researcher and watch them on their own. Each video also assigns a "homework" exercise for the participant to complete that week.

    Behavioral: Coping with Infertility Program

Interventions

  • BehavioralCoping with Infertility Program

    6 10-minute videos with assigned homework

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What researchers measure

Primary outcomes

  1. Fertility Quality of Life tool (Fertiqol)

    Pre-to-post change in quality of life related to a diagnosis of infertility. Scores range from 0-100, with higher scores indicating better quality of life

    Time frame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Pre-to-post change in anxious symptoms; Scores range from 0-21, with higher scores indicating more severe anxiety

    Time frame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)

  2. Patient Health Questionnaire-9 (PHQ-9)

    Pre-to-post change in depressive symptoms; Scores range from 0-27, with higher scores indicating more severe depressive symptoms

    Time frame: Pre-to-post change in the month following the intervention (post measures assessed 1, 2, 3, and 4 weeks after receipt of last module)

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05103982
Lead sponsor
University of Regina
Responsible party
Sponsor
First posted
Nov 2, 2021
Start date
Nov 1, 2021
Primary completion
Mar 1, 2022 (estimated)
Completion
Apr 15, 2022 (estimated)
Last update
Feb 1, 2022

Study contacts

Jennifer L Gordon, PhD
Contact
jennifer.gordon@uregina.ca
3063514976
Andreea Ababei, BA
Contact
wmh.research@uregina.ca
3065854992

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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