InfertilityNCT01119391
The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome
An observational study of Infertility, run by Boston IVF at 1 site in United States.
Trial summary
Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and… 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
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2010
- 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 18 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women about to undergo an in vitro fertilization cycle at Boston IVF
Who may be able to join
- Female Boston IVF infertility patient undergoing IVF treatment
- Age 18-44 years
- Able to read, understand and sign the informed consent in English
- 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
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Lifestyle Behaviors on IVF Outcome
Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF.
This is an observational study conducted at a private academically-affiliated infertility clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All subjects were asked to complete a health history survey at the time of enrollment and a daily survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.
- Conditions
- Infertility
- Being tested
- There was no intervention; this was 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 was no intervention; this was a survey only studyBehavioural
There was no intervention; this was a survey only study
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing IVF | Women undergoing an in vitro fertilization cycle Receives: Behavioral: There was no intervention; this was 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 posted7 May 2010 (estimated)
- Study startJul 2009
- Primary completionApr 2010
- Study completionApr 2010
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 118 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
- NCT01119391
- Sponsor's protocol ID
- 20091005
- Status last verified
- Feb 2016
- First submitted
- 5 May 2010
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Domar AD, Conboy L, Denardo-Roney J, Rooney KL. Lifestyle behaviors in women undergoing in vitro fertilization: a prospective study. Fertil Steril. 2012 Mar;97(3):697-701.e1. doi: 10.1016/j.fertnstert.2011.12.012. Epub 2012 Jan 3.
PubMed 22217965
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 Behaviors on IVF Outcome
- ClinicalTrials.gov ID
- NCT01119391
- Acronym / sponsor ID
- 20091005
- Conditions
- Infertility
- Keywords
- IVF, Lifestyle habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Boston IVFUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 7 May 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.
Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF.
This is an observational study conducted at a private academically-affiliated infertility clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All subjects were asked to complete a health history survey at the time of enrollment and a daily survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing IVF | – | Behavioral: There was no intervention; this was a survey only studyWomen undergoing an in vitro fertilization cycle |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women about to undergo an in vitro fertilization cycle at Boston IVF
Key inclusion criteria (5 listed)
- Female Boston IVF infertility patient undergoing IVF treatment
- Age 18-44 years
- Able to read, understand and sign the informed consent in English
- 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
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 was no intervention; this was a survey only studyThere was no intervention; this was 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.
- Derived from this study: PubMed 22217965Domar AD, Conboy L, Denardo-Roney J, Rooney KL. Lifestyle behaviors in women undergoing in vitro fertilization: a prospective study. Fertil Steril. 2012 Mar;97(3):697-701.e1. doi: 10.1016/j.fertnstert.2011.12.012. Epub 2012 Jan 3.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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 5 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?
On the ClinicalTrials.gov record for NCT01119391, 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.