NCT03712982

Attention to Variability During Infertility

Status unknown NA Last updated 26 October 2021

What this trial tests

NA trial testing Attention to Variability - Patient Only in Infertility in 160 participants. Status unknown.

Timeline

5 December 2016

Primary endpoint
5 December 2022

5 December 2022

Quick facts

Lead sponsor	Harvard University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	other
Enrollment	160
Start date	5 December 2016
Primary completion	5 December 2022
Estimated completion	5 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Attention to Variability - Patient Only
• Attention to Variability - Partner Only
• Attention to Variability - Patient & Partner
• Infertility Stories - Reading

Conditions studied

• Infertility — all drugs for Infertility →
• Infertility, Female — all drugs for Infertility, Female →
• Infertility, Male — all drugs for Infertility, Male →

Sponsor

Harvard University

Who can join

18 and older, any sex, with Infertility or Infertility, Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Infertility affects approximately one in seven couples, and it can be a devastating diagnosis and difficult experience for couples to endure. Ellen Langer, Ph.D., Director of the Langer Lab at Harvard, has spent several decades demonstrating evidence supporting a mind-body approach to improve wellbeing and overall functioning. Specifically, she asserts that Mindfulness in its most basic sense - paying attention in the moment - is enough to create both perceived (e.g., self-reported) and real (e.g., objective testing) change. Langer and her colleague, for example, demonstrated that "Trait mindfulness predicted the well-being of expecting mothers and better neonatal outcomes. Mindfulness training resulted in better health for the expecting mother". In this study, Mindfulness training refers to "attention to sensation variability." Such interventions are cost effective, minimally invasive, less time-consuming for practitioners and participants and generally easy to learn.

Langer and her colleague's study refers to pregnancy. Infertility is unlike pregnancy in its exact clinical diagnosis. Nevertheless, similar to pregnancy, infertility is considered a clinical condition affecting the body, in this case the reproductive system. Therefore, based on the results of studies like Langer and her colleague's, that used participants with clinical conditions affecting the reproductive system, the investigators propose similar mindfulness intervention (attention to sensation variability) research with infertile individuals. However, the investigators intend to extend our examination to also include a treatment group with the partners of the infertile individuals, as little, if any research, has attempted to do so previously. The investigators hypothesize that state mindfulness (groups exposed to mindfulness intervention) will improve wellbeing in the infertile patient and her partner and that trait mindfulness will predict ability to become pregnant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.