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

Completed

• Conditions: Lifestyle Factors
• Interventions: Other: Questionnaire

• Registration Number: NCT02072564
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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).

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 Timeline

• Study First Submitted: 2013-09-24
• Study Start: 2013-11
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-26
• Primary Completion: 2015-12
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Couples with indication for IVF	Questionnaire	Couples with primary or secondary infertility with indication of IVF

Primary Outcome Measures

Name	Time	Method
Live birth rate	One year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain