InfertilityNCT01404858
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome
An observational study of Infertility, run by Boston IVF at 1 site in United States.
Trial summary
The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 12,800 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2014
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Men and women undergoing IVF at a infertility clinic who uses eIVF, an electronic medical record collection entity specifically for IVF patients
Who may be able to join
- Eligible patients include, any patient whose:
- infertility clinic uses eIVF
- is scheduled to undergo an IVF cycle
- has access to the internet on a daily basis
- can read and understand English
- logs onto the patient portal on eIVF
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.
- Conditions
- Infertility
- Being tested
- There is no intervention; this is a survey only study
- Keywords
- IVF, Lifestyle habits
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention; this is a survey only studyBehavioural
There is no intervention; this is a survey only study
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing IVF | Not described Receives: Behavioral: There is no intervention; this is a survey only study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rates
Measured: Approximately 28 days (1 IVF cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionFeb 2014
- Study completionNov 2014
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,800 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
- NCT01404858
- Sponsor's protocol ID
- DC2011
- Status last verified
- Feb 2016
- First submitted
- 27 Jul 2011
- 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 Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome
- ClinicalTrials.gov ID
- NCT01404858
- Acronym / sponsor ID
- DC2011
- Conditions
- Infertility
- Keywords
- IVF, Lifestyle habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,800 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Jul 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 purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing IVF | – | Behavioral: There is no intervention; this is a survey only study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Men and women undergoing IVF at a infertility clinic who uses eIVF, an electronic medical record collection entity specifically for IVF patients
Key inclusion criteria (6 listed)
- infertility clinic uses eIVF
- is scheduled to undergo an IVF cycle
- has access to the internet on a daily basis
- can read and understand English
- logs onto the patient portal on eIVF
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| There is no intervention; this is a survey only studyThere is no intervention; this is a survey only study | Behavioural | Patients undergoing IVF |
Primary outcome
Clinical Pregnancy Rates
Time frame: Approximately 28 days (1 IVF cycle)
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.
- 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?
An observational study of 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 6 inclusion and 0 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. 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?
Clinical Pregnancy Rates (time frame: Approximately 28 days (1 IVF cycle)). 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.