Clinical trial NCT02236780: Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies
Official title: Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: In Vitro Fertilisation
Environmental Conditions
Keywords: in vitro fertilisation
environmental conditions
pregnancy
live birth rate
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: UPRES EA 2506 (Santé-Environnement-Vieillissement), France
First posted: 2014-09-11
Enrollment: 24000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study focuses on intraconjugal IVF attempts (conventional IVF, microinjection intra-cytoplasmic sperm injection (ICSI) and frozen embryo transfers) realised for MAP procedures in metropolitan France, in the period of 01/01/2008 to 12/31/2012 (5 years).

Brief summary: The main purpose of the study is to assess the impact of environmental conditions on live-birth rates after intraconjugal IVF.

The second purposes are

* to assess the impact on pregnancies (prematurity, preeclampsia);
* to assess the impact on newborn's health (stunted growth);
* to evaluate the consistency of results observed between assisted pregnancies and spontaneous pregnancies.

Detailed description: This multicenter epidemiological study aims to analyze the individual standardized clinical records, collected prospectively since 2008 in the medically assisted procreation centers (MAP).

These individual data will be mapped to the environmental data (meteorological and air quality), recorded in the area of residence of the mother at the time of conception and pregnancy, as well as to the socio-economic data.

Choice of centers:

* The study will be proposed to the 106 private or public centers in metropolitan France who are authorized for MAP procedures such as IVF and ICSI.
* Only the centers who perform more than 200 oocyte retrievals per year will be selected to participate in the study.

More than 80% of attempts performed by the selected centers should be available (without missing data) on the induced pregnancies and their outcome (minimum data set for each case: age of man and woman, cause of infertility, technique used, sperm collection method (ejaculation, surgical sperm retrieval techniques), total number of embryos obtained, clinical pregnancy or not, term of pregnancy, weight and height of the child at birth).

Eligibility criteria: Inclusion Criteria:

* Intraconjugal IVF and ICSI
* Transfers of frozen embryos after intraconjugal IVF or ICSI

Exclusion Criteria:

* IVF and ICSI with sperm donation
* IVF and ICSI with egg donation

Primary outcomes:
measure: Live birth rate
timeFrame: 1 year
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 year
measure: Rates of clinical pregnancy
timeFrame: 1 year
measure: Fetal growth restriction rate
timeFrame: 1 year
measure: Effect sizes and periods of susceptibility to environmental conditions
timeFrame: 5 years
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Alain BEAUCHET
state: Hauts-de-seine
Study officials:
affiliation: Hôpital Ambroise Paré, AP-HP
name: Alain BEAUCHET, MD
role: STUDY_CHAIR
affiliation: Hôpital Ambroise Paré, AP-HP
name: Philippe AEGERTER, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hôpital Jean Verdier, AP-HP
name: Rachel LEVY, MD, PhD
role: STUDY_DIRECTOR
References: