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Immune Modulators and IVF

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02626702
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : November 14, 2018
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:
Exploring the immune mediators of early pregnancy prospectively may help to identify new early interventions that will increase the likelihood of success and help women make informed decisions regarding their pregnancies.

Condition or disease Intervention/treatment
In Vitro Fertilization Other: Observational

Detailed Description:
Sera will be obtained from 500 women undergoing IVF at five time periods: cycle Day 2, post HCG, Day 24, Day 28, and/or Day 35.Aliquots of sera will be tested by commercial ELISA kits for concentrations of immune modulators suggestive to be predictive of IVF outcome, such as cytokines (interleukins, tumor necrosis factor, and interferon), neurotrophins (BDNF), protease inhibitors (HE4) and insulin-like growth factors (IGF-1, IGF-2, IGFBP). The results will be correlated with IVF outcomes.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Immune Modulators in Women Undergoing IVF----a Prospective Study
Study Start Date : July 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Intervention Details:
  • Other: Observational
    Excess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes.

Primary Outcome Measures :
  1. To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment. [ Time Frame: 35 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing In Vitro Fertilization.

Inclusion Criteria:

  • All fresh transfers

Exclusion Criteria:

  • PGD

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 identifier (NCT number): NCT02626702

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Contact: Mitasha C Joseph-Sohan, BSN, MPA 646-962-3382
Contact: Rodriq Stubbs, NP 646-962-3276

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United States, New York
Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine Recruiting
New York, New York, United States, 10021
Contact: Mitasha C. Joseph, BSN, MPA    646-962-3382   
Contact: Rodriq Stubbs, MSN    646-962-3276   
Principal Investigator: Steven Spandorfer, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University Identifier: NCT02626702     History of Changes
Other Study ID Numbers: 1502015953
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
immune modulators
IVF outcomes

Additional relevant MeSH terms:
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Immunologic Factors
Physiological Effects of Drugs