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

• Conditions: Environmental Conditions; In Vitro Fertilisation

• Registration Number: NCT02236780
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2014-09-08
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-11
• Study Start: 2015-01
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth rate	1 year	Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.

Secondary Outcome Measures

Name	Time	Method
Fertilization rate	1 year	Rate of fertilization (IVF and ICSI), rate of good quality embryos, rate of blastoformation (if prolonged culture), rate of embryo freezing.
Rates of clinical pregnancy	1 year	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).
Fetal growth restriction rate	1 year	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.
Effect sizes and periods of susceptibility to environmental conditions	5 years	Effect sizes and periods of susceptibility to environmental conditions among assisted pregnancies and spontaneous pregnancies.

Trial Locations

Locations (1)

Alain BEAUCHET; 🇫🇷 Boulogne-Billancourt, Hauts-de-seine, France