InfertilityNCT01156324
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
A study testing Online Stress Management Group (Upliv) in people with Infertility, run by Boston IVF at 1 site in United States.
Trial summary
The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Online Stress Management Group (Upliv)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2010
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female Boston IVF patients
- day three FSH 12 or below
- day three estradiol 80 pg/ml or below
- able to read, understand and sign the informed consent in English
- using own eggs (not egg donor)
- willing and able to comply with study requirements
- must be well versed in using a personal computer and the internet and must have access to an internet-connected computer seven days per week
Who cannot join
- prescription antipsychotic medication
- previous diagnosis of borderline or narcissistic personality disorder
- previous or concurrent participation in a mind/body group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of an Online Stress Management Program on IVF Outcome
The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.
Read the detailed description
The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.
In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.
- Conditions
- Infertility
- Being tested
- Online Stress Management Group (Upliv), Control
- Keywords
- IVF, Stress management
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Stress Management Group (Upliv)Behavioural
Personalized online stress management program
ControlBehavioural
Control group receiving routine care along with $50 gift certificate at end of cycle
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Participants of the routine care control group will each receive a $50 gift certificate at the end of each IVF cycle for which they completed the questionnaires. Receives: Behavioral: Online Stress Management Group (Upliv) |
| Online Stress Management Group (Upliv) | Experimental | Personalized online stress management program consisting of weekly sessions which each include relaxation exercises, stress management strategies, and lifestyle modification advice. Participants in Upliv will also be given a set of personal care products as part of the program. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rates
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
Measured: 1 year
Secondary outcomes (1)
Psychological Status
Psychological status is assessed by the following scales: Perceived Stress Scale (PSS), State Trait Anxiety Inventory (STAI), Beck Depression Inventory (BDI), Social Readjustment Scale (SRS), Daily Monitoring Form (DMF). Other than the DMF, these are all published validated scales.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Loss of funding.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston IVF
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice D. Domar, PhD, Boston IVF
- Investigators
- Alice D Domar, PhD, Principal investigator, Boston IVF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156324
- Sponsor's protocol ID
- 20100765
- Status last verified
- Feb 2016
- First submitted
- 29 Jun 2010
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- The Impact of an Online Stress Management Program on IVF Outcome
- ClinicalTrials.gov ID
- NCT01156324
- Acronym / sponsor ID
- 20100765
- Conditions
- Infertility
- Keywords
- IVF, Stress management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Loss of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Jul 2010 (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 goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.
Detailed description
The relationship between stress and infertility has remained a subject of controversy for many years. Recent research indicates that stress has a strong negative impact on pregnancy rates in women undergoing in vitro fertilization (IVF). In addition, stress is the most common reason given by women who voluntarily terminate treatment.
In a recent study, women who participated in a group mind/body treatment program had higher pregnancy rates than control subjects. The impact of an online stress management program has never been studied in the infertile population. An online intervention would be far more accessible for many infertility patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: Online Stress Management Group (Upliv)Participants of the routine care control group will each receive a $50 gift certificate at the end of each IVF cycle for which they completed the questionnaires. |
| Online Stress Management Group (Upliv) | Experimental | Behavioral: ControlPersonalized online stress management program consisting of weekly sessions which each include relaxation exercises, stress management strategies, and lifestyle modification advice. Participants in Upliv will also be given a set of personal care products as part of the program. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- female Boston IVF patients
- day three FSH 12 or below
- day three estradiol 80 pg/ml or below
- able to read, understand and sign the informed consent in English
- using own eggs (not egg donor)
Key exclusion criteria (3 listed)
- prescription antipsychotic medication
- previous diagnosis of borderline or narcissistic personality disorder
- previous or concurrent participation in a mind/body group
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 |
|---|---|---|
| Online Stress Management Group (Upliv)Personalized online stress management program | Behavioural | Control |
| ControlControl group receiving routine care along with $50 gift certificate at end of cycle | Behavioural | Online Stress Management Group (Upliv) |
Primary outcome
Clinical Pregnancy Rates
Time frame: 1 year
Clinical pregnancy rates will be recorded for IVF cycles 1 and 2.
1 secondary outcome
Psychological Status
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Stress Management Group (Upliv) 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 7 inclusion and 3 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical Pregnancy Rates (time frame: 1 year). 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 4 Feb 2016.