Lifestyle FactorsNCT02072564
Influence of Diet and Lifestyle Factors on the Results of the IVF
An observational study of Lifestyle Factors, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The purpose of this study is study the possible relationship between various lifestyle habits of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI). Read more about this study
- Who is it for?
- Ages 18 to 37 yearsHealthy volunteers can take part
- Conditions the study is for
- Lifestyle Factors
- What is being tested?
- Questionnaire
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2013to Apr 2016
- How long will I take part?
- 9 Months
- 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 37 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study sample is obtained from the population of infertile couples who meet the criteria for inclusion in a protocol for controlled ovarian stimulation for IVF/ICSI.
Who may be able to join
- Couples who want a pregnancy
- Mediterranean or Caucasian Ethnicity.
- Infertility to justify treatment with IVF / ICSI-TEI.
- First cycle of IVF / ICSI.
- Between 18 and 37 years (inclusive)
- Presence of one or both ovaries and uterus can withstand embryo implantation and pregnancy.
Show all 13Show fewer
- Body mass index (BMI) <40.
- Absence of pregnancy before starting ovarian stimulation.
- Having given their written consent.
- Unexplained vaginal bleeding.
- Any contraindication to become pregnant.
- Known allergy to preparations of gonadotropins or its excipients.
- Patients undergoing oocyte donation cycles -
Who cannot join
- Clinically important disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Influence of the Different Components of the Diet and Different Habits (Tobacco, Alcohol, Physical Exercise, Occupation) Results of IVF-ICSI
The purpose of this study is study the possible relationship between various lifestyle habits of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI).
Read the detailed description
It is a prospective study of couples with primary or secondary infertility, with indication for IVF. The main objective is to relate different lifestyle factors (age, BMI, physical activity, tobacco consumption, alchol, drugs, work and diet) with reproductive outcomes obtained in terms of total oocytes, M II, fertilization and implantation rates pregnancy and abortion rates and live birth. It also attempts to correlate the different habits of life in men with seminal parameters. For this, both members of the pair separately should answer a validated questionnaire before beginning the therapeutic process.
- Conditions
- Lifestyle Factors
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.
| Study group | Role | What they receive |
|---|---|---|
| Couples with indication for IVF | Couples with primary or secondary infertility with indication of IVF Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: One year
Secondary outcomes (8)
Pregnancy rate
Measured: 1 month
Number of mature oocytes
Measured: Two weeks
Fertilization rate
Measured: Two weeks
Cancelation rate
Measured: One month
Total dose
Total dose of gonadotrophins needed to stimulate the follicular growth
Measured: One month
Total Sperm count
Total number of spermatozoa in the seminal and number of spermatozoa/ml
Measured: Two weeks
Abortion rate
Measured: 16 weeks
Hyperstimulation rate
Moderate and severe hyperstimulation
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lifestyle FactorsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 9 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono International SA
- Responsible party
- Principal investigator, Juan Jose Espinos Gomez, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Investigators
- Juan José Espinós-Gómez, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072564
- Sponsor's protocol ID
- DYP-HAB-2010-01
- Other IDs
- Desarrollos y proyectos en RA
- Status last verified
- May 2016
- First submitted
- 24 Sep 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Influence of the Different Components of the Diet and Different Habits (Tobacco, Alcohol, Physical Exercise, Occupation) Results of IVF-ICSI
- ClinicalTrials.gov ID
- NCT02072564
- Acronym / sponsor ID
- DYP-HAB-2010-01
- Conditions
- Lifestyle Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Merck Serono International SA
- Study start
- Nov 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 26 Feb 2014 (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 study the possible relationship between various lifestyle habits of men and women (age, body mass index, diet, exercise, alcohol, tobacco, coffee, etc..) and live birth rate after in vitro fertilization-intracytoplasmatic injection (IVF-ICSI).
Detailed description
It is a prospective study of couples with primary or secondary infertility, with indication for IVF. The main objective is to relate different lifestyle factors (age, BMI, physical activity, tobacco consumption, alchol, drugs, work and diet) with reproductive outcomes obtained in terms of total oocytes, M II, fertilization and implantation rates pregnancy and abortion rates and live birth. It also attempts to correlate the different habits of life in men with seminal parameters. For this, both members of the pair separately should answer a validated questionnaire before beginning the therapeutic process.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Couples with indication for IVF | – | Other: QuestionnaireCouples with primary or secondary infertility with indication of IVF |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study sample is obtained from the population of infertile couples who meet the criteria for inclusion in a protocol for controlled ovarian stimulation for IVF/ICSI.
Key inclusion criteria (13 listed)
- Couples who want a pregnancy
- Mediterranean or Caucasian Ethnicity.
- Infertility to justify treatment with IVF / ICSI-TEI.
- First cycle of IVF / ICSI.
- Between 18 and 37 years (inclusive)
Key exclusion criteria (1 listed)
- Clinically important disease.
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 |
|---|---|---|
| QuestionnaireQuestionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet. | Other | Couples with indication for IVF |
Primary outcome
Live birth rate
Time frame: One year
8 secondary outcomes
Pregnancy rate
Time frame: 1 month
Number of mature oocytes
Time frame: Two weeks
Fertilization rate
Time frame: Two weeks
Cancelation rate
Time frame: One month
Total dose
Time frame: One month
Total Sperm count
Time frame: Two weeks
Abortion rate
Time frame: 16 weeks
Hyperstimulation rate
Time frame: One month
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 11 May 2016.
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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.
Juan José Espinós-Gómez, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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 Lifestyle Factors, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 13 inclusion and 1 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 11 May 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 Spain. 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?
Live birth rate (time frame: One 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 11 May 2016.