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

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).

Study Overview

• Status: Completed
• Conditions: Lifestyle Factors
• Intervention / Treatment: Other: Questionnaire

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Clinically important disease.
• Inclusion in previous cycles of assisted reproduction.
• Unexplained vaginal bleeding.
• Any contraindication to become pregnant.
• Known allergy to preparations of gonadotropins or its excipients.
• Patients undergoing oocyte donation cycles -

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Couples with indication for IVF; Couples with primary or secondary infertility with indication of IVF	Other: Questionnaire; Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Live birth rate	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate		1 month
Number of mature oocytes		Two weeks
Fertilization rate		Two weeks
Cancelation rate		One month
Total dose	Total dose of gonadotrophins needed to stimulate the follicular growth	One month
Total Sperm count	Total number of spermatozoa in the seminal and number of spermatozoa/ml	Two weeks
Abortion rate		16 weeks
Hyperstimulation rate	Moderate and severe hyperstimulation	One month

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Merck Serono International SA
• Investigators: Principal Investigator: Juan José Espinós-Gómez, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: September 24, 2013
• First Submitted That Met QC Criteria: February 25, 2014
• First Posted (Estimate): February 26, 2014

Study Record Updates

• Last Update Posted (Estimate): May 11, 2016
• Last Update Submitted That Met QC Criteria: May 10, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: DYP-HAB-2010-01; Desarrollos y proyectos en RA (Other Identifier: DYPRA)