In Vitro FertilizationNCT02626702
Immune Modulators and IVF
An observational study of In Vitro Fertilization, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Observational
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2015to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Study population: Subjects undergoing In Vitro Fertilization.
Who may be able to join
- All fresh transfers
Who cannot join
- PGD
Trial locations and contacts
1 site in 1 country.
United States1 site
Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine
New York, New York, 10021
About this study
Official title: Immune Modulators in Women Undergoing IVF----a Prospective Study
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.
Read the 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.
- Conditions
- In Vitro Fertilization
- Being tested
- Observational
- Keywords
- immune modulators, IVF outcomes, relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Excess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment.
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start31 Jul 2015
- Primary completion9 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Lab close down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Spandorfer, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626702
- Sponsor's protocol ID
- 1502015953
- Status last verified
- Sep 2019
- First submitted
- 7 Dec 2015
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Modulators in Women Undergoing IVF----a Prospective Study
- ClinicalTrials.gov ID
- NCT02626702
- Acronym / sponsor ID
- 1502015953
- Conditions
- In Vitro Fertilization
- Keywords
- immune modulators, IVF outcomes, relationship
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lab close down
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 31 Jul 2015
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects undergoing In Vitro Fertilization.
Key inclusion criteria (1 listed)
- All fresh transfers
Key exclusion criteria (1 listed)
- PGD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalExcess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes. | Other | – |
Primary outcome
To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment.
Time frame: 35 days
Results and safety
The study was stopped early (reason given: Lab close down). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Spandorfer, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of In Vitro Fertilization, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lab close down). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment. (time frame: 35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2019.