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

NCT ID: NCT02072564

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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

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Lifestyle Factors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Couples with indication for IVF

Couples with primary or secondary infertility with indication of IVF

Questionnaire

Intervention Type OTHER

Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.

Interventions

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Questionnaire

Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.

Intervention Type OTHER

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Serono International SA

INDUSTRY

Sponsor Role collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Juan Jose Espinos Gomez

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan José Espinós-Gómez, MD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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Desarrollos y proyectos en RA

Identifier Type: OTHER

Identifier Source: secondary_id

DYP-HAB-2010-01

Identifier Type: -

Identifier Source: org_study_id

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