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

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04151485
• Other study ID #: 83/2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 15, 2019
• Est. completion date: August 2023

Study information

• Verified date: May 2023
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 177
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Behavioral:
• Mind/Body Program for Fertility (Domar et al., 2011)
see Arm Description
• Fertility Support Program
see Arm Description

Locations

Country	Name	City	State
Hungary	Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University	Budapest
Hungary	Institute of Behavioral Sciences at Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Semmelweis University

Country where clinical trial is conducted

Hungary, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Number of oocytes retrieved	Number of oocytes retrieved at transvaginal oocyte retrieval (TVOR)	through study completion, an average of 2 years
Other	Number of oocytes fertilized	Number of oocytes fertilized via IVF/ICSI	through study completion, an average of 2 years
Other	Number of embryos transferred	Number of embryos transferred at embryo transfer (ET)	through study completion, an average of 2 years
Primary	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
Primary	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
Primary	Clinical pregnancy	Rate of clinical pregnancies at post-measurement	through study completion, an average of 2 years
Secondary	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