In Vitro FertilisationMeteoFIVNCT02236780
Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies
An observational study of In Vitro Fertilisation and Environmental Conditions, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- In Vitro Fertilisation, Environmental Conditions
- How many people
- 24,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Intraconjugal IVF and ICSI
- Transfers of frozen embryos after intraconjugal IVF or ICSI
Who cannot join
- IVF and ICSI with sperm donation
- IVF and ICSI with egg donation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Alain BEAUCHET
Boulogne-Billancourt, Hauts-de-seine, 92100
Alain BEAUCHET, MD, + 33 (0)1 49 09 56 68, alain.beauchet@aphp.fr
About this study
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.
Read the 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).
- Conditions
- In Vitro Fertilisation, Environmental Conditions
- Keywords
- in vitro fertilisation, environmental conditions, pregnancy, live birth rate
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.
Measured: 1 year
Secondary outcomes (4)
Fertilization rate
Rate of fertilization (IVF and ICSI), rate of good quality embryos, rate of blastoformation (if prolonged culture), rate of embryo freezing.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilisationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 24,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- UPRES EA 2506 (Santé-Environnement-Vieillissement), France
- Responsible party
- Sponsor
- Investigators
- Alain BEAUCHET, MD, Study chair, Hôpital Ambroise Paré, AP-HPPhilippe AEGERTER, MD, PhD, Study director, Hôpital Ambroise Paré, AP-HPRachel LEVY, MD, PhD, Study director, Hôpital Jean Verdier, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236780
- Sponsor's protocol ID
- AOR13130
- Acronym
- MeteoFIV
- Status last verified
- Nov 2017
- First submitted
- 8 Sep 2014
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Environmental Conditions on In Vitro Fertilization (IVF) Attempts and Induced Pregnancies
- ClinicalTrials.gov ID
- NCT02236780
- Acronym / sponsor ID
- MeteoFIV / AOR13130
- Conditions
- In Vitro Fertilisation, Environmental Conditions
- Keywords
- in vitro fertilisation, environmental conditions, pregnancy, live birth rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- UPRES EA 2506 (Santé-Environnement-Vieillissement), France
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Intraconjugal IVF and ICSI
- Transfers of frozen embryos after intraconjugal IVF or ICSI
Key exclusion criteria (2 listed)
- IVF and ICSI with sperm donation
- IVF and ICSI with egg donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth rate
Time frame: 1 year
Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.
4 secondary outcomes
Fertilization rate
Time frame: 1 year
Rates of clinical pregnancy
Time frame: 1 year
Fetal growth restriction rate
Time frame: 1 year
Effect sizes and periods of susceptibility to environmental conditions
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain BEAUCHET, MD study chair
Hôpital Ambroise Paré, AP-HP
Philippe AEGERTER, MD, PhD study director
Hôpital Ambroise Paré, AP-HP
Rachel LEVY, MD, PhD study director
Hôpital Jean Verdier, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilisation and Environmental Conditions, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain BEAUCHET, MD (+ 33 (0)1 49 09 56 68, alain.beauchet@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.