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

Lifestyle Factors Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072564
• Other study ID #: DYP-HAB-2010-01
• Secondary ID: Desarrollos y pr
• Status: Completed
• Phase: N/A
• First received: September 24, 2013
• Last updated: May 10, 2016
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 37 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lifestyle Factors

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Merck Serono International SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate		One year	No
Secondary	Pregnancy rate		1 month	No
Secondary	Number of mature oocytes		Two weeks	No
Secondary	Fertilization rate		Two weeks	No
Secondary	Cancelation rate		One month	No
Secondary	Total dose	Total dose of gonadotrophins needed to stimulate the follicular growth	One month	No
Secondary	Total Sperm count	Total number of spermatozoa in the seminal and number of spermatozoa/ml	Two weeks	No
Secondary	Abortion rate		16 weeks	No
Secondary	Hyperstimulation rate	Moderate and severe hyperstimulation	One month	Yes