NCT02236780

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

3 years

First QC Date

September 8, 2014

Last Update Submit

November 17, 2017

Conditions

In Vitro FertilisationEnvironmental Conditions

Keywords

in vitro fertilisationenvironmental conditionspregnancylive birth rate

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    Live birth rate after intraconjugal IVF (IVF and ICSI) by oocyte retrieval and by embryo transfer.

    1 year

Secondary Outcomes (4)

  • Fertilization rate

    1 year

  • Rates of clinical pregnancy

    1 year

  • Fetal growth restriction rate

    1 year

  • Effect sizes and periods of susceptibility to environmental conditions

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

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

You may not qualify if:

  • IVF and ICSI with sperm donation
  • IVF and ICSI with egg donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alain BEAUCHET

Boulogne-Billancourt, Hauts-de-seine, 92100, France

RECRUITING

Study Officials

  • Alain BEAUCHET, MD

    Hôpital Ambroise Paré, AP-HP

    STUDY CHAIR

  • Philippe AEGERTER, MD, PhD

    Hôpital Ambroise Paré, AP-HP

    STUDY DIRECTOR

  • Rachel LEVY, MD, PhD

    Hôpital Jean Verdier, AP-HP

    STUDY DIRECTOR

Central Study Contacts

Alain BEAUCHET, MD

CONTACT

+ 33 (0)1 49 09 56 68alain.beauchet@aphp.fr

Philippe AEGERTER, MD, PhD

CONTACT

+ 33 01 49 09 58 86philippe.aegerter@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 11, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

FR(1)