Maternal Serum Cytokine Levels and Angiogenic Factor Levels in IVF vs Spontaneously Conceived Pregnancies
2 other identifiers
observational
40
1 country
1
Brief Summary
The objective of the study is to compare maternal levels of cytokines and angiogenic factors in IVF vs spontaneously conceived singleton pregnancies. The null hypothesis is that there will be no significant difference.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2008
1 active site
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
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 4, 2009
CompletedFirst Posted
Study publicly available on registry
February 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedSeptember 18, 2009
September 1, 2009
1.7 years
February 4, 2009
September 17, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sFlt, human endoglin, PlGF, VEGF, IL-1, IL-2, IL-1ra, IL-4, IL-5, EGF, IL-6, Human IL-7, TGF, Fractalkine, IL-8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-1, IFN-gamma, G-CSF, GM-CSF, TNF, Eotaxin, MCP-1, sCD40L, IL-12p40, MIP-1, MIP-1ß, IP-10
10 months
Study Arms (2)
1 IVF
Pregnancies conceived with the use of assisted reproductive technologies. This is defined as a pregnancy conceived with all gametes being handled outside of the body.
2 Control
Spontaneously conceived pregnancies.
Eligibility Criteria
Healthy patients with singleton pregnancies conceived with ART. Only subjects that are already pregnant and have confirmed singleton intrauterine pregnancies are eligible.
You may qualify if:
- Healthy patients with singleton pregnancies conceived with ART and control subjects with spontaneously conceived pregnancies. Only subjects that are already pregnant and have confirmed singleton intrauterine pregnancies are eligible.
You may not qualify if:
- Subjects with hypertension, diabetes, renal disease, illicit drug use, tobacco use, morbid obesity, collagen vascular disease, and autoimmune diseases will be excluded from participation.
- Pregnancies that had more than one gestation viewed on ultrasound at any time will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MemorialCarelead
- University of California, Irvinecollaborator
Study Sites (1)
MemorialCare
Long Beach, California, 90806, United States
Biospecimen
Maternal blood draws are to be performed at four times. These are 10-15 weeks, 22-28 weeks, 34-40 weeks, and 4-8 weeks postpartum. Additionally, placental biopsies and umbilical cord blood specimens are to be collected for possible future analysis.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Chan, MD
MemorialCare
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 4, 2009
First Posted
February 5, 2009
Study Start
June 1, 2008
Primary Completion
March 1, 2010
Study Completion
June 1, 2010
Last Updated
September 18, 2009
Record last verified: 2009-09