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Prognostic Value of PIF Detection in Embryo Culture Media Correlation With Pregnancy Outcome (PIF-SET1)

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ClinicalTrials.gov Identifier: NCT01803893
Recruitment Status : Unknown
Verified March 2013 by BioIncept LLC.
Recruitment status was:  Enrolling by invitation
First Posted : March 4, 2013
Last Update Posted : March 4, 2013
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
BioIncept LLC

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.

Condition or disease
Pregnancy Fertility

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Preimplantation Factor (PIF): Prognostic Value of a Non-invasive Embryo Viability Biomarker Detection in Culture Media Followed by Single Embryo Transfer - Correlation With Live Birth.
Study Start Date : September 2012
Estimated Primary Completion Date : August 2014

Group/Cohort
Embryo culture media
measurement using immunoassay
maternal serum
measurement by immunoassay



Primary Outcome Measures :
  1. Detection of PIF in early pregnancy maternal serum [ Time Frame: end of pregnancy ]
    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.


Secondary Outcome Measures :
  1. Correlation between PIF positive and negative embryos and early pregnancy events [ Time Frame: end of pregnancy ]
    SET embryo transfers will be performed blinded, unrelated to PIF results. Subsequent to SET, the embryo culture media will be tested for presence/absence of PIF and documented. Following transfer, patients' pregnancy will be monitored by standard methods. This includes: blood tests and ultrasound to determine embryo viability.

  2. Correlation between PIF positive and negative embryos and late pregnancy events [ Time Frame: end of pregnancy ]
    SET embryo transfers will be performed blinded, unrelated to PIF results. Subsequent to SET, the embryo culture media will be tested for presence/absence of PIF and documented. Following transfer, patients' pregnancy will be monitored by standard methods. Once viability is established by standard methods, patients will be followed throughout pregnancy until eventual delivery. Premature delivery, high risk pregnancy events will be recorded.


Biospecimen Retention:   Samples Without DNA
embryo culture media


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infertile women attending IVF center who undergo in vitro fertilization in order to achieve pregnancy.
Criteria

Inclusion criteria:

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.

Exclusion criteria Women who will refuse to participate in the program.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803893


Locations
United States, Connecticut
Yale Women and Children's Center for Blood Disorders & Yale Fertility Center
New Haven, Connecticut, United States, 06511
France
Poissy St Germain Hospital
Poissy, Cedex, France, 78303
Lab Clement - Seine St. Denis Hospital, Le Blanc Mesnil
Paris, France, 93150
Versailles St. Quentin University
Poissy, France, 2493
Greece
Helena Venizelou Hospital
Athens, Greece, 11521
Sponsors and Collaborators
BioIncept LLC
Merck KGaA
Investigators
Study Chair: Eytan R Barnea, MD, FACOG BioIncept LLC

Responsible Party: BioIncept LLC
ClinicalTrials.gov Identifier: NCT01803893     History of Changes
Other Study ID Numbers: BioIncept LLC-1
GFI Merck Serono 2012 ( Other Grant/Funding Number: GFI-1 )
First Posted: March 4, 2013    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by BioIncept LLC:
In vitro fertilization
implantation
miscarriage
live birth