Recruiting
Phase 1
Phase 2

Self-help Intervention

Sponsor:

University of Regina

Code:

NCT05103982

Conditions

Infertility, Female

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

Interventions

Coping with Infertility Program

Study Details

Brief 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.

Conditions

Infertility, Female

Study ID

NCT05103982

Start date

Nov 1, 2021

Status verified date

Jan, 2022

Completion date

Apr 15, 2022

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 42

Healthy Volunteers: Not accepted

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:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Coping with Infertility Program

6 10-minute videos with assigned homework

Primary outcome measure

  • Fertility Quality of Life tool (Fertiqol) [ 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) ]

Central Contacts and Locations

Central contacts

Jennifer L Gordon, PhD

3063514976jennifer.gordon@uregina.ca

Andreea Ababei, BA

3065854992wmh.research@uregina.ca

Locations

University of Regina

Recruiting

Regina, Saskatchewan, Canada, S4S 0A2

Contacts

Jennifer Gordon, PhD

306-351-4976jennifer.gordon@uregina.ca

Andreea Ababei

wmh.research@uregina.ca

More Information

Sponsor

University of Regina

Last update posted

Feb 1, 2022

Last verified

Jan, 2022

Keywords

  • infertility-related distress
  • depression
  • anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Regina on 2022-02-01.