Ignite Creation Date:
2024-05-06 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03343405
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2017-09-19
Brief Title:
Online MindBody Program for Fertility
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Fertility Well-Being MindBody Protocol
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This pilot-study assesses the feasibility and acceptability of an Online MindBody Fertility Program designed to help individuals andor couples cope with the physical and emotional impact of infertility by learning special relaxation strategies and improving lifestyle habits Participants included women experiencing infertility who had not given birth to a child Half of participants received access to the 10-week Online Mind-Body Program and the other half were placed on a waiting-list
Detailed Description:
Infertility is defined as the inability to conceive a child A couple may be acknowledged as infertile if conception has not occurred after 12 months of having regular unprotected intercourse Over six million couples in the United States are affected by infertility Research suggests that there is a relationship between psychological distress and infertility but the relationship is complex The information from this study will be used to better understand the relationship between psychological distress and infertility among couples Furthermore the investigators are interested in testing Dr Alice Domars MindBody Fertility Program that was designed to help individuals regain control of their life and learn new lifestyle habits that can increase their chances of conceiving There is evidence that individuals that participated in the group format of this treatment protocol showed statistically significant decreases in physical and psychological symptoms of stress and increases in conception rates Our primary goals are to evaluate patients willingness to be recruited and randomized as well as their adherence and attrition to the program Our secondary goals are to evaluate reductions in emotional distress ie anxiety depression and stress and enhance emotion regulation skills as well as pregnancy rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None