InfertilityNCT01318291
Effect of Psychological Intervention on Drop-out Rates in IVF
A study testing CCRI Group in people with Infertility, run by Boston IVF at 1 site in United States.
Trial summary
The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment. The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- CCRI Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First fresh IVF cycle
- Using own eggs
- Able to read, understand, and sign the informed consent in English
- Must have insurance coverage for IVF cycle
Who cannot join
- >1 previous IVF cycle
- Donor egg cycle
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients
The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment.
The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
Read the detailed description
Intervention participants will be given a packet containing the CCRI, which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The cognitive component of the CCRI is the PRCI intervention (Boivin \& Lancastle, 2008) tailored to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future.
The relaxation components of the CCRI consists of techniques that have been used for two decades in the mind/body infertility program as well as in randomized controlled research trials. For the Stimulation phase, participants will receive instructions on how to do "mini relaxation" techniques which are specifically designed to reduce anxiety in the moment, for example feelings of tension, worry, and nervousness that might occur prior to and during Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting Phase the relaxation intervention will include a relaxation CD. The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The primary outcome measure is dropout rates.
- Conditions
- Infertility
- Being tested
- CCRI Group, Control
- Keywords
- IVF, Drop out
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CCRI GroupBehavioural
Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions
ControlBehavioural
Medical treatment alone
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Behavioral: Control |
| CCRI Group | Experimental | Not described Receives: Behavioral: CCRI Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop out rates
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Alice D. Domar, PhD, Boston IVF
- Investigators
- Alice D Domar, PhD, Principal investigator, Boston IVFJacky Boivin, PhD, Study director, School of Psychology, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318291
- Sponsor's protocol ID
- 38844
- Status last verified
- Feb 2016
- First submitted
- 16 Mar 2011
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
PubMed 26072382
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Effect of a Brief Psychological Intervention on Decreasing Drop-Out Rates in IVF Patients
- ClinicalTrials.gov ID
- NCT01318291
- Acronym / sponsor ID
- 38844
- Conditions
- Infertility
- Keywords
- IVF, Drop out
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 18 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most common reason why insured In Vitro Fertilization (IVF) patients drop out of treatment is the distress caused by the treatment.
The objective of this study is to determine the efficacy of a combined Cognitive Coping and Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
Detailed description
Intervention participants will be given a packet containing the CCRI, which consists of two intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The cognitive component of the CCRI is the PRCI intervention (Boivin \& Lancastle, 2008) tailored to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping that helps people think more about the positive aspects of a difficult situation and dwell less on problems or uncertainties of the future.
The relaxation components of the CCRI consists of techniques that have been used for two decades in the mind/body infertility program as well as in randomized controlled research trials. For the Stimulation phase, participants will receive instructions on how to do "mini relaxation" techniques which are specifically designed to reduce anxiety in the moment, for example feelings of tension, worry, and nervousness that might occur prior to and during Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting Phase the relaxation intervention will include a relaxation CD. The CD contains narrated instruction on how to elicit the relaxation response through several techniques
This is a randomized, controlled prospective study conducted at a private academically-affiliated infertility clinic and includes women ages 44 and below scheduled to undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The primary outcome measure is dropout rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Control |
| CCRI Group | Experimental | Behavioral: CCRI Group |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- First fresh IVF cycle
- Using own eggs
- Able to read, understand, and sign the informed consent in English
- Must have insurance coverage for IVF cycle
Key exclusion criteria (2 listed)
- >1 previous IVF cycle
- Donor egg cycle
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CCRI GroupCognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions | Behavioural | CCRI Group |
| ControlMedical treatment alone | Behavioural | Control |
Primary outcome
Drop out rates
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Derived from this study: PubMed 26072382Domar AD, Gross J, Rooney K, Boivin J. Exploratory randomized trial on the effect of a brief psychological intervention on emotions, quality of life, discontinuation, and pregnancy rates in in vitro fertilization patients. Fertil Steril. 2015 Aug;104(2):440-51.e7. doi: 10.1016/j.fertnstert.2015.05.009. Epub 2015 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice D Domar, PhD principal investigator
Boston IVF
Jacky Boivin, PhD study director
School of Psychology, Cardiff University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CCRI Group in people with Infertility, run by Boston IVF at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drop out rates (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01318291, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.