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

In Vitro Fertilisation Clinical Trial

— MeteoFIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02236780
• Other study ID #: AOR13130
• Status: Recruiting
• Phase: N/A
• First received: September 8, 2014
• Last updated: November 17, 2017
• Start date: January 2015
• Est. completion date: January 2018

Study information

• Verified date: November 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Alain BEAUCHET, MD
• Phone: + 33 (0)1 49 09 56 68
• Email: alain.beauchet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24000
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Environmental Conditions
• In Vitro Fertilisation

Locations

Country	Name	City	State
France	Alain BEAUCHET	Boulogne-Billancourt	Hauts-de-seine

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	UPRES EA 2506 (Santé-Environnement-Vieillissement), France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate	Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.	1 year
Secondary	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
Secondary	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
Secondary	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
Secondary	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