Lifestyle Factors
Conditions
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.
Interventions
OTHERQuestionnaire
Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.
Sponsors
Merck Serono International SA
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 37 Years
Healthy volunteers
Yes
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 -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate | One year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of mature oocytes | Two weeks | — |
| Fertilization rate | Two weeks | — |
| Cancelation rate | One month | — |
| Pregnancy rate | 1 month | — |
| Total Sperm count | Two weeks | Total number of spermatozoa in the seminal and number of spermatozoa/ml |
| Abortion rate | 16 weeks | — |
| Hyperstimulation rate | One month | Moderate and severe hyperstimulation |
| Total dose | One month | Total dose of gonadotrophins needed to stimulate the follicular growth |
Countries
Spain
Outcome results
None listed