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Maternal Serum Cytokine Levels and Angiogenic Factor Levels in IVF vs Spontaneously Conceived Pregnancies

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by MemorialCare.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00837278
First Posted: February 5, 2009
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, Irvine
Information provided by:
MemorialCare
  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

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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): 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

Responsible Party: Kenneth Chan, MD, MemorialCare
ClinicalTrials.gov Identifier: NCT00837278     History of Changes
Other Study ID Numbers: IVF cytokines
MHS IRB No. 525-08
First Submitted: February 4, 2009
First Posted: February 5, 2009
Last Update Posted: September 18, 2009
Last Verified: September 2009

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