Correlation Between PIF Maternal Serum Levels and Pregnancy Outcome

NCT01805102 | Unknown

• 2 other identifiers: BioIncept LLC-2GFI Merck Serono 2012
• Study Type: observational
• Target: 500
• Locations: 3 countries
• Sites: 5

Brief Summary

PIF: biomarker of pregnancy, miscarriage, premature birth, preeclampsia, placenta accreta. Except for serum hCG, no pregnancy-complication markers are widely employed to predict the need for medical intervention. Since circulating PIF is present from very early and throughout viable pregnancy, it may represent a specific biomarker candidate. PIF levels will be analyzed in serum of pregnant women in a range of settings: a) following IVF; b) index pregnancy of women with history of recurrent pregnancy loss, c) index pregnancy of women with history of placenta mediated complications such as: intrauterine growth restriction, spontaneous idiopathic preterm delivery, and preeclampsia; and d) index pregnancy in women with evidence of abnormal placentation, namely placenta accreta and related conditions.

Conditions

Pregnancy

Keywords

In vitro fertilization; implantation; miscarriage; live birth

Outcome Measures

Primary Outcomes (1)

• Maternal serum PIF levels correlation with pregnancy viability

  Maternal blood will be collected serially following implantation. PIF levels will be recorded. Patients will be followed by standard methods including blood tests and ultrasound until viability is established. Implantation failure (ie chemical pregnancy) miscarriage, evidence of gestational sac will be recorded.

  up to 12 weeks

Secondary Outcomes (1)

• Compare pregnancy outcome to low/high PIF levels in maternal blood

  up to live birth

Study Arms (1)

maternal serum

measurement by immunoassay

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women followed during pregnancy in perinatal centers

You may qualify if:

• Women attending a perinatal center who are properly informed and willing to participate in this study. Women included in the participating center with previous pregnancy complication and pregnant women after IVF (SET or MET). PIF levels evaluation in maternal serum (P1 to 5) will be evaluated for all pregnant women.

You may not qualify if:

• Women who will refuse to participate in the program.

Sponsors & Collaborators

• BioIncept LLC: lead
• Merck KGaA, Darmstadt, Germany: collaborator

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, 115 21, Greece

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

maternal blood

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Eytan R Barnea, MD

  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: March 1, 2013
• First Posted: March 6, 2013
• Study Start: September 1, 2012
• Primary Completion: August 1, 2014
• Last Updated: March 6, 2013

Record last verified: 2013-03

Locations

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