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Infertility, FemaleNCT04151485

The Effect of the Mind/Body Program for Fertility, Hungarian Version, on Well-Being and Assisted Reproduction Outcomes

A study testing Mind/Body Program for Fertility (Domar et al., 2011) and Fertility Support Program in people with Infertility, Female, run by Semmelweis University at 2 sites in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Involuntary childlessness is an emotionally stressful experience; however, psychosocial counseling is typically not available in Hungarian routine fertility care. The aim of this randomized controlled trial (RCT) is to examine the effectiveness of a Mind/Body psychological fertility intervention for women in… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Infertility, Female
What is being tested?
Mind/Body Program for Fertility (Domar et al., 2011) and Fertility Support Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
2 sitesHungary
Study dates
15 Dec 2019to Aug 2023
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 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • active psychotic episode
  • severe depression or other major psychiatric diagnoses
  • substance abuse
  • eating disorders

Trial locations and contacts

2 sites in 1 country.

Hungary2 sites

  • Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University

    Budapest, 1082

  • Institute of Behavioral Sciences at Semmelweis University

    Budapest, 1089

Other trials in Hungary

About this study

Official title: The Effect of the Mind/Body Program for Fertility, Hungarian Version, on Psychological Well-Being and Assisted Reproduction Technology (ART) Outcomes: A Randomized Controlled Trial

Involuntary childlessness is an emotionally stressful experience; however, psychosocial counseling is typically not available in Hungarian routine fertility care. The aim of this randomized controlled trial (RCT) is to examine the effectiveness of a Mind/Body psychological fertility intervention for women in reproductive treatment. We hypothesize that participants of the Mind/Body Program for Fertility, Hungarian version, will have more favorable psychological well-being, ART outcome results than participants of the Fertility Support Groups.

Read the detailed description

Involuntary childlessness imposes significant psychological burden on those affected, particularly those involved in assisted reproductive technology (ART). The reduction of psychological distress has been shown to improve the quality of life of those affected and to possibly increase chances of pregnancy. While in more developed countries psychological support is largely available in routine fertility care, it is not yet part of the Hungarian ART protocol.

In this study, the effects of a psychosocial intervention, namely, the Hungarian version of the Mind/Body Program for Fertility (Domar et al., 2011), will be tested on the psychological well-being and ART outcomes of women in reproductive treatment, in a randomized controlled pre-post design.

For this purpose, women in ART treatment will fill in screening questionnaires (on depression, anxiety, stress, etc.), and moderate to high scorers will be randomized into an intervention (Mind/Body) group (N=70) and a comparison intervention (Fertility Support) group (N=70), lasting for 10 weeks each, before and/or during an ART cycle. Both interventions will be delivered by the same clinical psychologist, listed as central contact person below, officially trained in the Mind/Body Program for Fertility by Dr. Alice Domar at Boston IVF, Waltham, Massachusetts. A smartphone application for rating subjective stress levels twice a day, from the start of the stimulation to the day of the pregnancy test, will also be administered. Additionally, whole-night sleep EEGs will be recorded.

Medical data (such as diagnosis, hormone levels, previous treatment cycles, etc.) and sociodemographic (such as age, education, etc.) and psychological variables (such as personality traits, chronotype, intelligence, etc.) as potential moderators, as well as ART outcomes will be reported. Data of respondents willing to fill in pre- and post-questionnaires but 1) not motivated to take part in the study, or 2) motivated to take part in the study, but not able to make it, will be registered but excluded from statistical analysis comparing RCT results.

Being tested
Mind/Body Program for Fertility (Domar et al., 2011), Fertility Support Program
Keywords
female infertility, assisted reproductive technology, in vitro fertilization, intra-cytoplasmic sperm injection, pregnancy, stress, depression, anxiety, quality of life, sleep quality, circadian rhythm, mind/body
Medical subject headings
Infertility, Female, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders

What participants receive

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

  • Mind/Body Program for Fertility (Domar et al., 2011)Behavioural

    see Arm Description

  • Fertility Support ProgramBehavioural

    see Arm Description

Study groups in NCT04151485
Study groupRoleWhat they receive
Mind/Body GroupExperimentalAll persons allocated to the intervention group will take part in a 10-week Mind/Body skills development fertility program parallel with fertility workup and treatment.
Receives: Behavioral: Mind/Body Program for Fertility (Domar et al., 2011)
Support GroupActive comparatorAll persons allocated to the comparison intervention group will take part in a 10-week fertility support program parallel with fertility workup and treatment.
Receives: Behavioral: Fertility Support Program

What is being measured

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

  1. Mean change from baseline in results on the Fertility Quality of Life tool

    Mean change from baseline in results on the Fertility Quality of Life (FertiQoL) Core Scale, subscales and Treatment Module

    Measured: through study completion, an average of 2 years

  2. Mean change from baseline in results on the SCREENIVF tool

    Mean change from baseline in results on the SCREENIVF tool and its subscales

    Measured: through study completion, an average of 2 years

  3. Clinical pregnancy

    Rate of clinical pregnancies at post-measurement

    Measured: through study completion, an average of 2 years

Secondary outcomes (1)

  1. Mean change from baseline on a Likert scale measuring strength of intention to continue treatment

    Mean change from baseline on a 10-point Likert scale measuring strength of intention to continue treatment (if first ART cycle not successful) to post-measurement

    Measured: through study completion, an average of 2 years

Timeline

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

  1. First posted5 Nov 2019
  2. Study start15 Dec 2019
  3. Primary completionJul 2023 (estimated)
  4. Study completionAug 2023 (estimated)

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Mind/Body and Fertility Support Groups will be running in a parallel manner, with continuous enrollment on the basis of pre-generated random number tables. Each group will consist of 10-16 members, and run for 10 weeks. Every 11th week two new groups (one Mind/Body and one Fertility Support) will be scheduled, and so on, until the desired number of participants will be collected.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
177 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151485
Sponsor's protocol ID
83/2019
Status last verified
May 2023
First submitted
28 Oct 2019
Last updated
3 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Domar AD, Rooney KL, Wiegand B, Orav EJ, Alper MM, Berger BM, Nikolovski J. Impact of a group mind/body intervention on pregnancy rates in IVF patients. Fertil Steril. 2011 Jun;95(7):2269-73. doi: 10.1016/j.fertnstert.2011.03.046. Epub 2011 Apr 15.

    PubMed 21496800

  • Szigeti F J, Kazinczi C, Szabo G, Sipos M, Ujma PP, Purebl G. The clinical effectiveness of the Mind/Body Program for Infertility on wellbeing and assisted reproduction outcomes: a randomized controlled trial in search for active ingredients. Hum Reprod. 2024 Aug 1;39(8):1735-1751. doi: 10.1093/humrep/deae119.

    PubMed 38852061

Questions about this trial

What is this clinical trial studying?

A study testing Mind/Body Program for Fertility (Domar et al., 2011) and Fertility Support Program in people with Infertility, Female, run by Semmelweis University at 2 sites in Hungary.

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 0 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hungary. 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?

Results are not available in the source record.

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?

Mean change from baseline in results on the Fertility Quality of Life tool (time frame: through study completion, an average of 2 years). The study lists 3 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 NCT04151485, which also lists 2 linked publications.

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 3 May 2023.

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