NCT03118219

Brief Summary

Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
401

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

March 29, 2017

Last Update Submit

September 26, 2019

Conditions

Infertility/Sterility

Keywords

assisted reproductive technologyembryo transferonline interventionrct

Outcome Measures

Primary Outcomes (1)

  • Differences in the Screen IVF questionaire between the intervention groups

    Differences in the ScreenIVF risk profile at post-measurement time between the intervention group of positive adjustment and the intervention comparison group with the brainteasers

    through study completion, an average of 2 years

Secondary Outcomes (2)

  • Quantitative evaluation of participants' opinion about the intervention

    through study completion, an average of 2 years

  • Qualitative evaluation of participants' opinion about the intervention

    through study completion, an average of 2 years

Study Arms (2)

Positive adjustment coping intervention

EXPERIMENTAL

All persons allocated to the intervention group will receive daily text messages (SMS) to their smartphones with sentences for positive adjustment over two weeks starting from the day of the egg-cell punctuation.

Other: Positive adjustment coping intervention

Brainteaser

OTHER

All persons allocated to the comparison intervention group will receive daily text messages (SMS) to their smartphones with brainteasers over two weeks starting from the day of the egg-cell punctuation.

Other: Brainteaser

Interventions

Positive adjustment coping interventionOTHER

see arm description

Positive adjustment coping intervention
BrainteaserOTHER

see arm description

Also known as: Comparison intervention group
Brainteaser

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All couples undergoing infertility treatment (in vitro fertilization or intracytoplasmic sperm injection) at the Department of Gynecologic Endocrinology and Fertility Disorders at Heidelberg University Women's Hospital, which have
  • agreed to participate in the study
  • indicated their mobile phone number
  • sufficient knowledge of German language.
  • If one partner is refusing to participate, the other person may be admitted as an individual.

You may not qualify if:

  • denial of participation
  • non-existent smartphone
  • insufficient knowledge of German language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (4)

  • Lancastle D, Boivin J. A feasibility study of a brief coping intervention (PRCI) for the waiting period before a pregnancy test during fertility treatment. Hum Reprod. 2008 Oct;23(10):2299-307. doi: 10.1093/humrep/den257. Epub 2008 Jul 15.

    PMID: 18628259BACKGROUND

  • Kremer F, Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: A randomised controlled trial. PLoS One. 2025 Dec 8;20(12):e0335776. doi: 10.1371/journal.pone.0335776. eCollection 2025.

    PMID: 41359611DERIVED

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

    PMID: 32779730DERIVED

  • Schick M, Roesner S, Germeyer A, Moessner M, Bauer S, Ditzen B, Wischmann T. Smartphone-supported Positive Adjustment Coping Intervention (PACI) for couples undergoing fertility treatment: a randomised controlled trial protocol. BMJ Open. 2019 Jul 9;9(7):e025288. doi: 10.1136/bmjopen-2018-025288.

    PMID: 31289056DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Tewes Wischmann, PD Dr.

    University Hospital Heidelberg

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 18, 2017

Study Start

July 18, 2017

Primary Completion

June 12, 2019

Study Completion

August 8, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)