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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility, Female
• Intervention / Treatment: Behavioral: Mind/Body Program for Fertility (Domar et al., 2011); Behavioral: Fertility Support Program

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.

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1082
    • Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University
  • Budapest, Hungary, 1089
    • Institute of Behavioral Sciences at Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind/Body Group; 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); see Arm Description
Active Comparator: Support Group; 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

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	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)	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)	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	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	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)	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)	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)	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	through study completion, an average of 2 years
Number of oocytes retrieved	Number of oocytes retrieved at transvaginal oocyte retrieval (TVOR)	through study completion, an average of 2 years
Number of oocytes fertilized	Number of oocytes fertilized via IVF/ICSI	through study completion, an average of 2 years
Number of embryos transferred	Number of embryos transferred at embryo transfer (ET)	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: György Purebl, PhD Ass.Prof, Institute of Behavioural Sciences, Semmelweis University, Budapest

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2019
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 2, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; depression; anxiety; pregnancy; stress; circadian rhythm; sleep quality; in vitro fertilization; assisted reproductive technology; female infertility; intra-cytoplasmic sperm injection; mind/body
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 83/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No