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

NCT04151485 | Unknown

• 1 other identifier: 83/2019
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mean change from baseline on a Likert scale measuring strength of intention to continue treatment

  through study completion, an average of 2 years

Other Outcomes (16)

• 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 World Health Organisation-Five Well-Being Index

  through study completion, an average of 2 years

• Mean change from baseline in results on the Spielberger State-Trait Anxiety Inventory

  through study completion, an average of 2 years

Study Arms (2)

Mind/Body Group

EXPERIMENTAL

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)

Support Group

ACTIVE COMPARATOR

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

Interventions

Mind/Body Program for Fertility (Domar et al., 2011) BEHAVIORAL

see Arm Description

Mind/Body Group

Fertility Support Program BEHAVIORAL

see Arm Description

Support Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (2)

Assisted Reproduction Center of the Department of Obstetrics and Gynecology at Semmelweis University

Budapest, 1082, Hungary

Location

Institute of Behavioral Sciences at Semmelweis University

Budapest, 1089, Hungary

Location

Related Publications (2)

• 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.

  PMID: 21496800 BACKGROUND

• Szigeti F J, Kazinczi C, Szabo G, Sipos M, Ujma PP, Purebl G. The clinical effectiveness of the Mind/Body Program for Infertility on wellbeing and assisted reproduction outcomes: a randomized controlled trial in search for active ingredients. Hum Reprod. 2024 Aug 1;39(8):1735-1751. doi: 10.1093/humrep/deae119.

  PMID: 38852061 DERIVED

MeSH Terms

Conditions

Infertility, Female; Depression; Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Fertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Behavioral Symptoms; Behavior; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• György Purebl, PhD Ass.Prof

  Institute of Behavioural Sciences, Semmelweis University, Budapest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: December 15, 2019
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)