Immune Modulators and IVF
Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Terminated
CT.gov ID
NCT02626702
Collaborator
(none)
500
1
49
10.2
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
500 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Immune Modulators in Women Undergoing IVF----a Prospective Study
Study Start Date
:
Jul 31, 2015
Actual Primary Completion Date
:
Aug 9, 2019
Actual Study Completion Date
:
Aug 31, 2019
Outcome Measures
Primary Outcome Measures
- To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment. [35 days]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 44 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- All fresh transfers
Exclusion Criteria:
- PGD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Steven Spandorfer, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT02626702
Other Study ID Numbers:
- 1502015953
First Posted:
Dec 10, 2015
Last Update Posted:
Sep 16, 2019
Last Verified:
Sep 1, 2019
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