Clinical trial NCT02072564: Influence of Diet and Lifestyle Factors on the Results of the IVF
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lifestyle Factors
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Merck Serono International SA
First posted: 2014-02-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Live birth rate
timeFrame: One year
Secondary outcomes:
measure: Pregnancy rate
timeFrame: 1 month
measure: Number of mature oocytes
timeFrame: Two weeks
measure: Fertilization rate
timeFrame: Two weeks
measure: Cancelation rate
timeFrame: One month
measure: Total dose
timeFrame: One month
measure: Total Sperm count
timeFrame: Two weeks
measure: Abortion rate
timeFrame: 16 weeks
measure: Hyperstimulation rate
timeFrame: One month
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Juan José Espinós-Gómez, MD
role: PRINCIPAL_INVESTIGATOR
References: