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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
BioIncept LLC
ClinicalTrials.gov Identifier:
NCT01803893
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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
Pregnancy
Fertility

Study Type: Observational
Study Design: 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.

Further study details as provided by BioIncept LLC:

Primary Outcome Measures:
  • Detection of PIF in early pregnancy maternal serum [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
    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:
  • Correlation between PIF positive and negative embryos and early pregnancy events [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
    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.

  • Correlation between PIF positive and negative embryos and late pregnancy events [ Time Frame: end of pregnancy ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 500
Study Start Date: September 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Embryo culture media
measurement using immunoassay
maternal serum
measurement by immunoassay

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: BioIncept LLC
ClinicalTrials.gov Identifier: NCT01803893     History of Changes
Other Study ID Numbers: BioIncept LLC-1, GFI Merck Serono 2012
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: France: Committee for the Protection of Personnes

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

ClinicalTrials.gov processed this record on July 20, 2014