Influence of Diet and Lifestyle Factors on the Results of the IVF
Pilot Study on the Influence of the Different Components of the Diet and Different Habits (Tobacco, Alcohol, Physical Exercise, Occupation) Results of IVF-ICSI
2 other identifiers
observational
300
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2013
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 11, 2016
May 1, 2016
2.1 years
September 24, 2013
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Live birth rate
One year
Secondary Outcomes (8)
Pregnancy rate
1 month
Number of mature oocytes
Two weeks
Fertilization rate
Two weeks
Cancelation rate
One month
Total dose
One month
- +3 more secondary outcomes
Study Arms (1)
Couples with indication for IVF
Couples with primary or secondary infertility with indication of IVF
Interventions
Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.
Eligibility Criteria
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.
You may qualify if:
- 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.
- Body mass index (BMI) \<40.
- Absence of pregnancy before starting ovarian stimulation.
- Having given their written consent.
You may not qualify if:
- Clinically important disease.
- Unexplained vaginal bleeding.
- Any contraindication to become pregnant.
- Known allergy to preparations of gonadotropins or its excipients.
- Patients undergoing oocyte donation cycles -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan José Espinós-Gómez, MD
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 24, 2013
First Posted
February 26, 2014
Study Start
November 1, 2013
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-05