Infertility, Female
Conditions
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
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.
Interventions
BEHAVIORALMind/Body Program for Fertility (Domar et al., 2011)
see Arm Description
BEHAVIORALFertility Support Program
see Arm Description
Sponsors
Semmelweis University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants, statisticians and medical staff will be blinded for intervention allocation. Since, to control the therapist variable, the two types of interventions will be done by the same person, blinding on the Care Provider's part is not possible.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in results on the Fertility Quality of Life tool | through study completion, an average of 2 years | Mean change from baseline in results on the Fertility Quality of Life (FertiQoL) Core Scale, subscales and Treatment Module |
| Mean change from baseline in results on the SCREENIVF tool | through study completion, an average of 2 years | Mean change from baseline in results on the SCREENIVF tool and its subscales |
| Clinical pregnancy | through study completion, an average of 2 years | Rate of clinical pregnancies at post-measurement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline on a Likert scale measuring strength of intention to continue treatment | through study completion, an average of 2 years | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in results on the Perceived Stress Scale | through study completion, an average of 2 years | Mean change from baseline in results on the 10-item Perceived Stress Scale (PSS-10) |
| Mean change from baseline in results on the Life Meaning subscale of the Brief Stress and Coping Inventory | through study completion, an average of 2 years | Mean change from baseline in results on the 7-item Life Meaning subscale of the Brief Stress and Coping Inventory (BSCI-LM) |
| 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 | through study completion, an average of 2 years | 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) |
| 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 | through study completion, an average of 2 years | 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 |
| Mean change from baseline in results on the Sexual Concerns subscale of the Fertility Problem Inventory | through study completion, an average of 2 years | Mean change from baseline in results on the 8-item Sexual Concerns subscale of the Fertility Problem Inventory |
| Mean change from baseline in results on the Relationship Assessment Scale | through study completion, an average of 2 years | Mean change from baseline in results on the 7-item Relationship Assessment Scale (RAS) |
| Mean change from baseline in results on the Beck Depression Inventory | through study completion, an average of 2 years | 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) |
| Mean change from baseline in results on the Athens Insomnia Scale | through study completion, an average of 2 years | Mean change from baseline in results on the 8-item Athens Insomnia Scale (AIS) |
| Mean results on a smartphone-based Likert-scale rating momentary stress | through study completion, an average of 2 years | Mean results on the StressFlash smartphone-based Likert-scale rating momentary stress |
| Number of oocytes retrieved | through study completion, an average of 2 years | Number of oocytes retrieved at transvaginal oocyte retrieval (TVOR) |
| Number of oocytes fertilized | through study completion, an average of 2 years | Number of oocytes fertilized via IVF/ICSI |
| Number of embryos transferred | through study completion, an average of 2 years | Number of embryos transferred at embryo transfer (ET) |
| Mean change from baseline in results on the Pittsburgh Sleep Quality Index | through study completion, an average of 2 years | Mean change from baseline in results on the Pittsburgh Sleep Quality Index (PSQI) |
| Mean change from baseline in results on the World Health Organisation-Five Well-Being Index | through study completion, an average of 2 years | Mean change from baseline in results on the 5-item World Health Organisation-Five Well-Being Index (WHO-5) |
| Mean change from baseline in results on the Spielberger State-Trait Anxiety Inventory | through study completion, an average of 2 years | Mean change from baseline in results on the State and Trait subscales of the Spielberger State Trait Anxiety Inventory (STAI) |
| Mean change from baseline in results on the Short Stress Scale | through study completion, an average of 2 years | Mean change from baseline in results on the 26-item Short Stress Scale (SSS) |
Countries
Hungary
Outcome results
None listed