Intervention for Sterility, Female

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sterility, Female+1 More
Infertility ACTion Program - Behavioral
Eligibility
18 - 65
Female
What conditions do you have?
Select

Study Summary

This RCT will test the effect of a 6-week self-help ACT-based program in improving fertility-related quality of life and psychological flexibility, in women with infertility.

Eligible Conditions
  • Sterility, Female

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Pre-to-post change in the month following the intervention (post measures assessed 4 weeks after receipt of last module)

At the 1-month post-intervention follow-up time point, participants will be asked to collect a small lock of hair for the measurement of chronic cortisol exposure.
Hair Cortisol
Week 4
Fertility Quality of Life tool (Fertiqol)
Generalized Anxiety Disorder-7 (GAD-7)
Patient Health Questionnaire-9 (PHQ-9)

Trial Safety

Trial Design

2 Treatment Groups

Waistlist
1 of 2
Intervention
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · No Placebo Group · N/A

Intervention
Behavioral
Experimental Group · 1 Intervention: Infertility ACTion Program · Intervention Types: Behavioral
WaistlistNoIntervention Group · 1 Intervention: Waistlist · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-to-post change in the month following the intervention (post measures assessed 4 weeks after receipt of last module)

Who is running the clinical trial?

University of ReginaLead Sponsor
40 Previous Clinical Trials
6,778 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are trying to become pregnant and have not been successful OR are currently undergoing fertility treatments.
You have a high level of distress related to infertility, as indicated by a FertiQoL score below 52.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 23rd, 2021

Last Reviewed: November 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Regina100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%