Maternal Serum Cytokine Levels and Angiogenic Factor Levels in IVF vs Spontaneously Conceived Pregnancies
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by MemorialCare.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
MemorialCare
Collaborator:
University of California, Irvine
Information provided by:
MemorialCare
ClinicalTrials.gov Identifier:
NCT00837278
First received: February 4, 2009
Last updated: September 17, 2009
Last verified: September 2009
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Purpose
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.
| Condition |
|---|
|
Infertility |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Maternal Serum Cytokine Levels and Angiogenic Factor Levels in Singleton IVF Pregnancies vs Spontaneously Conceived Pregnancies |
Resource links provided by NLM:
Further study details as provided by MemorialCare:
Primary Outcome Measures:
- 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 [ Time Frame: 10 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
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.
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Healthy patients with singleton pregnancies conceived with ART. Only subjects that are already pregnant and have confirmed singleton intrauterine pregnancies are eligible.
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837278
Contacts
| Contact: Christine Preslicka, RN | 562-933-2755 | cpreslicka@memorialcare.org |
Locations
| United States, California | |
| MemorialCare | Recruiting |
| Long Beach, California, United States, 90806 | |
| Contact: Christine Preslicka, RN 562-933-2755 cpreslicka@memorialcare.org | |
| Contact: Robert M Ehsanipoor, MD 562-933-2755 rehsanip@uci.edu | |
| Principal Investigator: Kenneth Chan, MD | |
Sponsors and Collaborators
MemorialCare
University of California, Irvine
Investigators
| Principal Investigator: | Kenneth Chan, MD | MemorialCare |
More Information
No publications provided
| Responsible Party: | Kenneth Chan, MD, MemorialCare |
| ClinicalTrials.gov Identifier: | NCT00837278 History of Changes |
| Other Study ID Numbers: | IVF cytokines, MHS IRB No. 525-08 |
| Study First Received: | February 4, 2009 |
| Last Updated: | September 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by MemorialCare:
|
IVF angiogenic factors cytokines |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female Angiogenesis Inducing Agents |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013