Attention to Variability During Infertility

NCT03712982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

Attention to Variability - Patient Only

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

BEHAVIORAL

Attention to Variability - Partner Only

In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and physiology in their partner that occur throughout the day, to notice when a symptom is better or worse and to ask why it may be.

BEHAVIORAL

Attention to Variability - Patient & Partner

Same as patient and partner only conditions, just that in this condition both the patient and partner do their corresponding intervention rather than only one of them.

OTHER

Infertility Stories - Reading

Reading Stories About Others' Infertility Experiences

Sponsors & Collaborators

Principal Investigators

  • Karyn Gunnet-Shoval, PhD · Harvard University

  • Katherine Bercovitz · Harvard University

  • Ellen Langer, PhD · Harvard University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-05
Primary Completion
2019-12-18
Completion
2021-01-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712982 on ClinicalTrials.gov