NCT01803893

Brief Summary

PIF: biomarker of successful implantation To overcome the poor reproductive potential of embryos generated during in vitro fertilization cycles and the lack of markers enabling the identification of the most competent ones, it is common to transfer multiple embryos. However this practice is associated with the risks of multi-fetal pregnancies and high morbidity/mortality. Ideally, the availability of a marker specifically produced by viable embryos would permit the transfer of a single embryo (SET) without affecting the chances of pregnancy and, most importantly, capable to drastically reduce multiple pregnancies after IVF. In preliminary work, we demonstrated that no pregnancy resulted following the transfer of embryos where PIF was undetectable in culture media.(Keramitsoglou, T et al. ASRI Meeting, Hamburg, 2012) Using a non-invasive method of detection of PIF in the media surrounding the embryo will be correlated to live birth following single embryo transfer. By selecting only viable embryos, it will reduce the need for multiple IVF cycles, increase the rate of pregnancy outcome associated with SET, and will minimize multi-fetal pregnancy that has very high medical and societal costs both in pregnancy and after delivery.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
3 countries

5 active sites

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

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

1.9 years

First QC Date

February 28, 2013

Last Update Submit

March 1, 2013

Conditions

PregnancyFertility

Keywords

In vitro fertilizationimplantationmiscarriagelive birth

Outcome Measures

Primary Outcomes (1)

  • Detection of PIF in early pregnancy maternal serum

    Following PIF positive single embryo transfer, patients' pregnancy will be monitored by standard methods. This includes: blood tests and ultrasound until pregnancy viability has been established. The number of patients that fail to implant or end up in implantation failure (ie chemical pregnancy), miscarriage, gestational sac will be recorded.

    end of pregnancy

Secondary Outcomes (2)

  • Correlation between PIF positive and negative embryos and early pregnancy events

    end of pregnancy

  • Correlation between PIF positive and negative embryos and late pregnancy events

    end of pregnancy

Study Arms (2)

Embryo culture media

measurement using immunoassay

maternal serum

measurement by immunoassay

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Infertile women attending IVF center who undergo in vitro fertilization in order to achieve pregnancy.

You may qualify if:

  • All women included in our centers for classical IVF or ICSI, who will sign the written consent to participate in the study. PIF level evaluation in culture media (M) and pregnancy prognosis (S1 and S2) will be done only for women with SET.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Yale Women and Children's Center for Blood Disorders & Yale Fertility Center

New Haven, Connecticut, 06511, United States

Location

Poissy St Germain Hospital

Poissy, Cedex, 78303, France

Location

Lab Clement - Seine St. Denis Hospital, Le Blanc Mesnil

Paris, 93150, France

Location

Versailles St. Quentin University

Poissy, 2493, France

Location

Helena Venizelou Hospital

Athens, 11521, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

embryo culture media

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Eytan R Barnea, MD, FACOG

    BioIncept LLC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2013

First Posted

March 4, 2013

Study Start

September 1, 2012

Primary Completion

August 1, 2014

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

FR(3)GR(1)US(1)