Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies (MeteoFIV)

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.

Study Overview

• Status: Unknown
• Conditions: In Vitro Fertilisation; Environmental Conditions

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).

• Study Type: Observational
• Enrollment (Anticipated): 24000

Contacts and Locations

Study Locations

• France
  • Hauts-de-seine
    • Boulogne-Billancourt, Hauts-de-seine, France, 92100
      • Recruiting
      • Alain BEAUCHET
      • Contact: Alain BEAUCHET, MD; Phone Number: + 33 (0)1 49 09 56 68; Email: alain.beauchet@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate	Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization rate	Rate of fertilization (IVF and ICSI), rate of good quality embryos, rate of blastoformation (if prolonged culture), rate of embryo freezing.	1 year
Rates of clinical pregnancy	Rates of assisted pregnancy, rate of spontaneous miscarriage, rate of medical termination of pregnancy, rate of pathology of pregnancy (pre-eclampsia, gestational diabetes, placenta praevia, signs of preterm labor with hospitalization).	1 year
Fetal growth restriction rate	Fetal growth restriction rate, biometrics of child at birth (height, weight, head circumference, Body Mass Index), preterm birth rate, transfer rate to intensive care units.	1 year
Effect sizes and periods of susceptibility to environmental conditions	Effect sizes and periods of susceptibility to environmental conditions among assisted pregnancies and spontaneous pregnancies.	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: UPRES EA 2506 (Santé-Environnement-Vieillissement), France
• Investigators: Study Director: Philippe AEGERTER, MD, PhD, Hôpital Ambroise Paré, AP-HP; Study Chair: Alain BEAUCHET, MD, Hôpital Ambroise Paré, AP-HP; Study Director: Rachel LEVY, MD, PhD, Hôpital Jean Verdier, AP-HP

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 8, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): November 20, 2017
• Last Update Submitted That Met QC Criteria: November 17, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: pregnancy; in vitro fertilisation; live birth rate; environmental conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: AOR13130