An interventional study of Mind/Body Program for Fertility (Domar et al., 2011) and Fertility Support Program in Infertility, Female, sponsored by Semmelweis University. Status unknown at 2 sites in Hungary. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-05-03.
Sponsored by Semmelweis University · Not applicable, Interventional, and Supportive care
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.
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.
553 studies on the registry are indexed under Infertility, Female; 136 are open to participants now.
This study's enrollment of 177 is above the median of 100 across 377 interventional studies indexed under Infertility, Female.
Browse Infertility, Female studies →Semmelweis University is the lead sponsor of 139 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: All women awaiting or undergoing infertility treatment (insemination, in vitro fertilization or intracytoplasmic sperm injection) at the Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University, Budapest, who:
Exclusion Criteria:
All 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.
Behavioral: Mind/Body Program for Fertility (Domar et al., 2011)
All persons allocated to the comparison intervention group will take part in a 10-week fertility support program parallel with fertility workup and treatment.
Behavioral: Fertility Support Program
see Arm Description
see Arm Description
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
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the SCREENIVF tool
Mean change from baseline in results on the SCREENIVF tool and its subscales
Time frame: through study completion, an average of 2 years
Clinical pregnancy
Rate of clinical pregnancies at post-measurement
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Beck Depression Inventory
Mean change from baseline in results on the 21-item Beck Depression Inventory (BDI), with special attention to category change (e.g. from moderate to mild depression level, from mild to no depression)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the World Health Organisation-Five Well-Being Index
Mean change from baseline in results on the 5-item World Health Organisation-Five Well-Being Index (WHO-5)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Spielberger State-Trait Anxiety Inventory
Mean change from baseline in results on the State and Trait subscales of the Spielberger State Trait Anxiety Inventory (STAI)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Short Stress Scale
Mean change from baseline in results on the 26-item Short Stress Scale (SSS)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Perceived Stress Scale
Mean change from baseline in results on the 10-item Perceived Stress Scale (PSS-10)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Life Meaning subscale of the Brief Stress and Coping Inventory
Mean change from baseline in results on the 7-item Life Meaning subscale of the Brief Stress and Coping Inventory (BSCI-LM)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Awareness of Mind-Body Integration and the Trusting Body Sensations subscales of the Multidimensional Assessment of Interoceptive Awareness
Mean change from baseline in results on the 12-item Awareness of Mind-Body Integration and the 3-item Trusting Body Sensations subscales of the Multidimensional Assessment of Interoceptive Awareness (MAIA)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Fertility Problem Stress Scales and the Coping Strategy Scales of the Copenhagen Multi-centre Psychosocial Infertility study questionnaire
Mean change from baseline in results on the 14-item Fertility Problem Stress Scales and the 19-item Coping Strategy Scales of the Copenhagen Multi-centre Psychosocial Infertility (COMPI) study questionnaire
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Sexual Concerns subscale of the Fertility Problem Inventory
Mean change from baseline in results on the 8-item Sexual Concerns subscale of the Fertility Problem Inventory
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Relationship Assessment Scale
Mean change from baseline in results on the 7-item Relationship Assessment Scale (RAS)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Pittsburgh Sleep Quality Index
Mean change from baseline in results on the Pittsburgh Sleep Quality Index (PSQI)
Time frame: through study completion, an average of 2 years
Mean change from baseline in results on the Athens Insomnia Scale
Mean change from baseline in results on the 8-item Athens Insomnia Scale (AIS)
Time frame: through study completion, an average of 2 years
Mean results on a smartphone-based Likert-scale rating momentary stress
Mean results on the StressFlash smartphone-based Likert-scale rating momentary stress
Time frame: through study completion, an average of 2 years
Number of oocytes retrieved
Number of oocytes retrieved at transvaginal oocyte retrieval (TVOR)
Time frame: through study completion, an average of 2 years
Number of oocytes fertilized
Number of oocytes fertilized via IVF/ICSI
Time frame: through study completion, an average of 2 years
Number of embryos transferred
Number of embryos transferred at embryo transfer (ET)
Time frame: through study completion, an average of 2 years
Plan to share: No
Started Dec 2019 (actual). Primary completion is estimated for Jul 2023, 43 months after the start.
Of 139 non-industry interventional studies with no phase under Infertility, Female, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 43 months is above that.
Counting every sponsor, half of 152 studies reached it within 23 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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