NCT01701011

Brief Summary

Background of the study: Undergoing an IVF or ICSI treatment is an emotional and physical burden for both the woman and her partner. Most stressful for the couple is waiting for the result of the treatment, the period after the embryotransfer until the pregnancy test or menstruation and an unsuccessful treatment. Symptoms of anxiety and depression have been identified in couples during the waitingperiod after an embryotransfer. For this waitingperiod a short selfhelp copingintervention has been developed based on the stress theory of Lazarus for women to use at home. Goal of the instrument is to stimulate the copingstyle positive reappraisal. Research has demonstrated that using this copingstyle can have a positive impact in health related circumstances.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
377

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable anxiety

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

Study Start

First participant enrolled

October 1, 2010

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 years until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 22, 2014

Completed
Last Updated

August 10, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

October 6, 2010

Results QC Date

December 3, 2014

Last Update Submit

June 28, 2016

Conditions

AnxietyDepression

Keywords

copinginterventionwaiting-period

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    The Hospital Anxiety and Depression Scale (HADS) was used to measure general anxiety and depression (Zigmond and Snaith, 1983). TheHADSconsists of 14 items (7 items for each subscale) that are rated on a 4-point Likert scale. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0 to 21). Scores on each scale can be interpreted in ranges: normal (0-7), mild (8-10), moderate (11-14) and severe (15-21) anxiety and depression.

    T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer

Secondary Outcomes (1)

  • Depression

    T1 during the first week of the stimulation phase, T2 on the 10th day after embryo transfer, T3 six weeks after embryo transfer

Study Arms (3)

PRCI-monitoring

EXPERIMENTAL

Coping intervention, Daily Record Keeping, Questionnaires

Behavioral: Coping intervention

Routine care control

NO INTERVENTION

Questionnaires

Monitoring control

NO INTERVENTION

DRK and Questionnaires

Interventions

Coping interventionBEHAVIORAL

Positive reappraisal coping intervention

PRCI-monitoring

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient in IVF/ICSI treatment

You may not qualify if:

  • Patient who do not speak the dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Utrecht, : PO Box 85500, Netherlands

Location

Related Publications (2)

  • Ockhuijsen H, van den Hoogen A, Eijkemans M, Macklon N, Boivin J. The impact of a self-administered coping intervention on emotional well-being in women awaiting the outcome of IVF treatment: a randomized controlled trial. Hum Reprod. 2014 Jul;29(7):1459-70. doi: 10.1093/humrep/deu093. Epub 2014 May 7.

    PMID: 24812317DERIVED

  • Ockhuijsen HD, van den Hoogen A, Macklon NS, Boivin J. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment. BMC Womens Health. 2013 Sep 3;13:35. doi: 10.1186/1472-6874-13-35.

    PMID: 24004640DERIVED

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Results Point of Contact

Title
Henrietta Ockhuijsen 1,*, Agnes van den Hoogen, Marinus Eijkemans , Nick Macklon, Jacky Boivin
Organization
UMCU
h.d.l.ockhuysen@umcutrecht.nl
+31307553628

Study Officials

  • N.S. Macklon, MD, PhD

    University of Southampton

    PRINCIPAL INVESTIGATOR

  • J Boivin, PhD

    Cardiff University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
prof

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 4, 2012

Study Start

October 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

August 10, 2016

Results First Posted

December 22, 2014

Record last verified: 2016-06

Locations

NL(1)