InfertilityPhase 2NCT01714882
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
A Phase 2 study testing Stress Management & Resiliency Training and Stress Management DVD in people with Infertility, run by Amit Sood at 1 site in United States.
Trial summary
The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF). Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Infertility
- What is being tested?
- Stress Management & Resiliency Training and Stress Management DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Sep 2015
- Phase
- Phase 2
- 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 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
- Women with a partner, and both are willing to provide consent for study participation as a couple
- Couples that can be reached by telephone for follow-up
Who cannot join
- Women less than 18 years of age
- Women equal or greater than 40 years of age
- Women with a history of recurrent pregnancy loss
- History of current or recent psychotic episode within past 6 months for either the woman or her partner
- Couples needing a interpreter for their clinical encounter
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)
The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
Read the detailed description
The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.
- Conditions
- Infertility
- Being tested
- Stress Management & Resiliency Training, Stress Management DVD
- Keywords
- Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management & Resiliency TrainingBehavioural
The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
Stress Management DVDBehavioural
The couples in this group will receive a Mayo Clinic Stress Management DVD.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management & Resiliency Training | Experimental | The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program. Receives: Behavioral: Stress Management & Resiliency Training |
| Stress Management DVD | Active comparator | The couples in this group will receive a Mayo Clinic Stress Management DVD. Receives: Behavioral: Stress Management DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Scores from questionnaires from baseline to 6 and then 12 weeks
Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
Measured: Baseline, 6 and 12 weeks after randomization
Secondary outcomes (1)
Clinical Pregnancy rate
Clinical pregnancy rate: which is defined as seeing a gestational sac in the uterus with a fetal pole that has a heart beat.
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amit Sood
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amit Sood, Mayo Clinic
- Investigators
- Amit Sood, MD, Principal investigator, Mayo ClinicZaraq Khan, MBBS, Study chair, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714882
- Sponsor's protocol ID
- 12-007272
- Status last verified
- Nov 2015
- First submitted
- 18 Oct 2012
- Last updated
- 6 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Management for Couples With Infertility Undergoing In Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT01714882
- Acronym / sponsor ID
- 12-007272
- Conditions
- Infertility
- Keywords
- Infertility, In Vitro Fertilization (IVF), Stress Management, Stress Reduction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Amit SoodUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 26 Oct 2012 (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 investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).
Detailed description
The investigators are trying to determine two different stress management techniques in couples undergoing IVF. One arm will be randomized to learning these techniques by themselves by watching and following instructions on a digital video disc (DVD). The other arm will have an in-person class that will teach the couples different stress reduction techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management & Resiliency Training | Experimental | Behavioral: Stress Management & Resiliency TrainingThe couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program. |
| Stress Management DVD | Active comparator | Behavioral: Stress Management DVDThe couples in this group will receive a Mayo Clinic Stress Management DVD. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with clinical infertility, either primary or secondary, who are recommended for IVF for the first time as part of their treatment for infertility
- Women with a partner, and both are willing to provide consent for study participation as a couple
- Couples that can be reached by telephone for follow-up
Key exclusion criteria (5 listed)
- Women less than 18 years of age
- Women equal or greater than 40 years of age
- Women with a history of recurrent pregnancy loss
- History of current or recent psychotic episode within past 6 months for either the woman or her partner
- Couples needing a interpreter for their clinical encounter
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 |
|---|---|---|
| Stress Management & Resiliency TrainingThe couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program. | Behavioural | Stress Management & Resiliency Training |
| Stress Management DVDThe couples in this group will receive a Mayo Clinic Stress Management DVD. | Behavioural | Stress Management DVD |
Primary outcome
Change of Scores from questionnaires from baseline to 6 and then 12 weeks
Time frame: Baseline, 6 and 12 weeks after randomization
Primary outcome measure will be comparison of pre- and post-stress reduction treatment questionnaire scale scores.
1 secondary outcome
Clinical Pregnancy rate
Time frame: 12 months after randomization
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 6 Nov 2015.
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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.
Amit Sood, MD principal investigator
Mayo Clinic
Zaraq Khan, MBBS study chair
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stress Management & Resiliency Training and Stress Management DVD in people with Infertility, run by Amit Sood 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 3 inclusion and 5 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 6 Nov 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of Scores from questionnaires from baseline to 6 and then 12 weeks (time frame: Baseline, 6 and 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2015.