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

Study Overview
=================
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.

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

Conditions
-----------------
Infertility, Female

Intervention / Treatment
-----------------
* Behavioral: Mind/Body Program for Fertility (Domar et al., 2011)
* Behavioral: Fertility Support Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind/Body Group<br>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)<br>* see Arm Description<br>|
| Active Comparator: Support Group<br>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<br>* see Arm Description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | through study completion, an average of 2 years | 
| Clinical pregnancy | Rate of clinical pregnancies at post-measurement | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | through study completion, an average of 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
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