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InfertilityNCT03712982

Attention to Variability During Infertility

A study testing Attention to Variability - Patient Only, Attention to Variability - Partner Only and Attention to Variability - Patient & Partner in people with Infertility and Infertility, Female, run by Harvard University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Attention to Variability - Patient Only, Attention to Variability - Partner Only and Attention to Variability - Patient & Partner
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
5 Dec 2016to 29 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18+ years of age;
  • Female patients who have been trying to conceive for at least a year, have attended at least one doctor's appointment with an infertility/fertility specialist and have been advised by their physician to undergo their first IVF cycle;
  • Participants (patients and partners) with no known biological children.

Who cannot join

  • Individuals who do not meet the inclusion criteria above;
  • Participants (patients and partners) with secondary infertility (already have a child);
  • Participants (patients and partners) with a cut point score of less than 60 on the Mental Health Inventory (MHI-5) (assessed at phone screening).

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston IVF/IVF New England

    Waltham, Massachusetts, 02451

Other trials in United States

About this study

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.

Read the detailed description

Couples who have been trying to conceive for at least a year, have attended at least one doctor's appointment with an infertility/fertility specialist and have been advised by their physician to undergo their first IVF cycle will be recruited for this study.

Participants (couples) will be randomly assigned (assignment determined immediately following recruitment by a member of our research team), if eligible to one of four of five experimental conditions, which are described below. Assignment will occur on a 1:2:2:2:1 basis, such that for every two couples assigned to Conditions 2, 3 and 4 (mindfulness conditions) one couple will be assigned to Conditions 1 and 5 (control conditions). Couples will be told that we are interested in exploring if practicing mindful attention during the IVF process may improve patient and partner wellbeing during and following their first IVF cycle. All participants will be instructed to complete study measures, at three different points in time, via an online link.

Being tested
Attention to Variability - Patient Only, Attention to Variability - Partner Only, Attention to Variability - Patient & Partner, Infertility Stories - Reading
Keywords
Infertility, Fertility, Mindfulness, Ellen Langer, Wellbeing, Attention to Variability
Medical subject headings
Infertility, Infertility, Female, Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Attention to Variability - Patient OnlyBehavioural

    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.

  • Attention to Variability - Partner OnlyBehavioural

    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.

  • Attention to Variability - Patient & PartnerBehavioural

    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.

  • Infertility Stories - ReadingOther

    Also called Reading Activity

    Reading Stories About Others' Infertility Experiences

Study groups in NCT03712982
Study groupRoleWhat they receive
Waitlist ControlNo interventionAll participants in this condition will complete all measures online at three different points in time, including one narrative response at T2.
Attention to Variability - Patient OnlyExperimentalAll participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. They will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).
Receives: Behavioral: Attention to Variability - Patient Only
Attention to Variability - Partner OnlyExperimentalAll participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. Partners of the infertile women will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).
Receives: Behavioral: Attention to Variability - Partner Only
Attention to Variability - Patient & PartnerExperimentalAll participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. All participants (patients and partners) will also be instructed to complete a mindfulness intervention at home and respond to diary-type text messaging questions twice daily for two weeks (14 days).
Receives: Behavioral: Attention to Variability - Patient & Partner
Infertility Stories - ReadingActive comparatorAll participants in this condition will complete all measures online at three different points in time, including one narrative response at T2. They will also be instructed to do an at-home reading activity several times over a period of 2 weeks.
Receives: Other: Infertility Stories - Reading

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS)

    4 subscales, each ranging from 1-7, with 1 being 'Strongly Disagree' and 7 being 'Strongly Agree'. Subscales are 'Flexibility' (includes 4 items); 'Novelty Seeking' (6 items); 'Novelty Producing' (6 items); 'Engagement' (5 items). 7 items are reverse scored. To determine overall Mindfulness score, sum all items (items 1-21).

    Measured: Approximately 8 minutes

  2. Patient and Partner Wellbeing - Positive and Negative Affect Schedule (PANAS)

    Scale consists of a number of words that describe different feelings and emotions. Participants indicate to what extent they have a particular way in the past few hours. The scale ranges from 1 (Very slightly or not at all) to 5 (extremely).

    Individuals decide which of the 20 questions are positive and which are negative. Scores are then added for the 10 positive words and separately for the 10 negative words. The scores generated will vary along the scale of 10 - 50, with lower scores indicating low (positive or negative) affect and higher scores indicating high (positive or negative) affect.

    Measured: Approximately 8 minutes

  3. Patient and Partner Wellbeing - Rosenberg Self-Esteem Scale (RSE)

    A 10-item scale that measures global self-worth by measuring both positive and negative feelings about the self. The scale is believed to be unidimensional. All items are answered using a 4-point Likert scale format ranging from 1 (strongly agree) to 4 (strongly disagree).

    Scoring: Items 2, 5, 6, 8, 9 are reverse scored. Scores are then summed for all ten items on a continuous scale. Higher scores indicate higher self-esteem.

    Measured: Approximately 5 minutes

  4. Patient and Partner Wellbeing - Satisfaction With Life Scale (SWLS)

    A 5-item scale designed to measure global cognitive judgments of one's life satisfaction. Participants indicate how much they agree or disagree with each of the 5 items using a 7-point scale that ranges from 1 (strongly disagree) to 1 (strongly agree).

    Scoring : Scoring should be kept continuous (scores are summed up on each item).

    Measured: Approximately 3 minutes

  5. Patient and Partner Wellbeing - Perceived Stress Scale (PSS)

    The following questions ask about one's feelings and thoughts during the past month. In each question, individuals are asked how often they felt or thought a certain way.

    Scoring: Each item is rated on a 5-point scale ranging from (0) never to (4) almost always. Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress. PSS-10 scores are obtained by reversing the scores on the four positive items: For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items.

    Measured: Approximately 5 minutes

  6. Patient and Partner Wellbeing - Couples Satisfaction Index (CSI)

    A 32-item scale designed to measure one's satisfaction in a relationship. The scale has a variety of items with different response scales and formats.

    Question Scoring:

    1: 0 (Extremely Unhappy) to 6 (Perfect); 2-4: 0 (Always Disagree) to 5 (Always Agree); 5: 0 (Never) to 5 (All the time); 6: 0 (All the time) to 5 (Never); 7-18: 0 (Not at all True) to 5 (Completely True); 19-22: 0 (Not at All) to 5 (Completely); 23: 0 (Worse than all others [extremely bad]) to 5 (Better than all others [extremely good]); 24-25: 0 (Never) - 5 (More Often); 26: 0 (Boring) to 5 (Interesting); 27: 0 (Bad) to 5 (Good); 28: 0 (Empty) to 5 (Full); 29: 0 (Lonely) to 5 (Friendly); 30: 0 (Fragile) to Sturdy (5); 31: 0 (Discouraging) to 5 (Hopeful); 32: 0 (Miserable) to 5 (Enjoyable).

    Measured: Approximately 11 minutes

  7. Patient and Partner Wellbeing - Tolerance of Ambiguity Scale

    The instrument consists of 16 items on a scale ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).

    High scores indicate a greater intolerance for ambiguity. To score the instrument, the even-numbered items must be reverse-scored. Three subscales can also be computed to reveal the major source of intolerance of ambiguity - novelty (N), complexity (c), or insolubility (I).

    Having intolerance of ambiguity means that an individual tends to perceive situations as threatening rather than promising. Lack of information or uncertainty, for example, would make such a person uncomfortable. Ambiguity arises from three main sources: novelty, complexity and insolubility.

    Measured: Approximately 10 minutes

  8. Patient and Partner Wellbeing - Narrative question about their mind-body experience

    Narrative question about their mind-body experience over the past three weeks

    Measured: Approximately 8 minutes

Secondary outcomes (1)
  1. Ability to become pregnant

    Question about whether or not they got pregnant

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2018
  2. Study start5 Dec 2016
  3. Primary completion18 Dec 2019
  4. Study completion29 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03712982
Sponsor's protocol ID
IRB16-1683
Status last verified
Apr 2026
First submitted
25 Sep 2018
Last updated
21 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zilcha-Mano S, Langer E. Mindful Attention to Variability Intervention and Successful Pregnancy Outcomes. J Clin Psychol. 2016 Sep;72(9):897-907. doi: 10.1002/jclp.22294. Epub 2016 Mar 23.

    PubMed 27007939

Questions about this trial

What is this clinical trial studying?

A study testing Attention to Variability - Patient Only, Attention to Variability - Partner Only and Attention to Variability - Patient & Partner in people with Infertility and Infertility, Female, run by Harvard University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient and Partner Wellbeing - Langer Mindfulness Scale (LMS) (time frame: Approximately 8 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712982, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.

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