Influence of Diet and Lifestyle Factors on the Results of the IVF

May 10, 2016 updated by: Juan Jose Espinos Gomez, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: One year
One year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe