Clinical trial NCT04151485: The Effect of the Mind/Body Program for Fertility, Hungarian Version, on Well-Being and Assisted Reproduction Outcomes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility, Female
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
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

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.

Eligibility criteria: 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:

* give informed consent to participating in the study
* have sufficient knowledge of the Hungarian language

Exclusion Criteria:

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

Primary outcomes:
measure: Mean change from baseline in results on the Fertility Quality of Life tool
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the SCREENIVF tool
timeFrame: through study completion, an average of 2 years
measure: Clinical pregnancy
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Mean change from baseline on a Likert scale measuring strength of intention to continue treatment
timeFrame: through study completion, an average of 2 years
Other outcomes:
measure: Mean change from baseline in results on the Beck Depression Inventory
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the World Health Organisation-Five Well-Being Index
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Spielberger State-Trait Anxiety Inventory
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Short Stress Scale
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Perceived Stress Scale
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Life Meaning subscale of the Brief Stress and Coping Inventory
timeFrame: through study completion, an average of 2 years
measure: 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
timeFrame: through study completion, an average of 2 years
measure: 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
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Sexual Concerns subscale of the Fertility Problem Inventory
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Relationship Assessment Scale
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Pittsburgh Sleep Quality Index
timeFrame: through study completion, an average of 2 years
measure: Mean change from baseline in results on the Athens Insomnia Scale
timeFrame: through study completion, an average of 2 years
measure: Mean results on a smartphone-based Likert-scale rating momentary stress
timeFrame: through study completion, an average of 2 years
measure: Number of oocytes retrieved
timeFrame: through study completion, an average of 2 years
measure: Number of oocytes fertilized
timeFrame: through study completion, an average of 2 years
measure: Number of embryos transferred
timeFrame: through study completion, an average of 2 years
Locations:
city: Budapest
country: Hungary
facility: Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University
city: Budapest
country: Hungary
facility: Institute of Behavioral Sciences at Semmelweis University
Study officials:
affiliation: Institute of Behavioural Sciences, Semmelweis University, Budapest
name: György Purebl, PhD Ass.Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.