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

NCT ID: NCT05103982

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2022-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility, Female

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Coping with Infertility Program

Intervention Type BEHAVIORAL

6 10-minute videos with assigned homework

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Coping with Infertility Program

6 10-minute videos with assigned homework

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Regina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Regina

Regina, Saskatchewan, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jennifer L Gordon, PhD

Role: CONTACT

3063514976

Andreea Ababei, BA

Role: CONTACT

3065854992

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jennifer Gordon, PhD

Role: primary

306-351-4976

Andreea Ababei

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Poulter MML, Balsom AA, Gordon JL. Pilot trial of a new self-directed psychological intervention for infertility-related distress. Pilot Feasibility Stud. 2024 Aug 16;10(1):111. doi: 10.1186/s40814-024-01535-y.

Reference Type DERIVED
PMID: 39152484 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-108

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Contraception Navigator Program
NCT05691270 COMPLETED NA
Strategies for Pregnancy Achievement
NCT03085212 ACTIVE_NOT_RECRUITING NA
fertiShare Evaluation
NCT06587360 RECRUITING NA