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Completed

NCT Number: NCT02072564

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

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).

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Key information

Conditions

Age range

18 year–37 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Questionnaire

Other

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

Primary outcomes

  1. Live birth rate

    Time frame: One year

Secondary outcomes

  1. Pregnancy rate

    Time frame: 1 month

  2. Number of mature oocytes

    Time frame: Two weeks

  3. Fertilization rate

    Time frame: Two weeks

  4. Cancelation rate

    Time frame: One month

  5. Total dose

    Time frame: One month

    Total dose of gonadotrophins needed to stimulate the follicular growth

  6. Total Sperm count

    Time frame: Two weeks

    Total number of spermatozoa in the seminal and number of spermatozoa/ml

  7. Abortion rate

    Time frame: 16 weeks

  8. Hyperstimulation rate

    Time frame: One month

    Moderate and severe hyperstimulation

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Merck Serono International SA

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 26, 2014
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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