NCT02626702

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

September 16, 2019

Status Verified

September 1, 2019

Enrollment Period

4 years

First QC Date

December 7, 2015

Last Update Submit

September 11, 2019

Conditions

In Vitro Fertilization

Keywords

immune modulatorsIVF outcomesrelationship

Outcome Measures

Primary Outcomes (1)

  • To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment.

    35 days

Interventions

ObservationalOTHER

Excess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes.

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects undergoing In Vitro Fertilization.

You may qualify if:

  • All fresh transfers

You may not qualify if:

  • PGD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Steven Spandorfer, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 10, 2015

Study Start

July 31, 2015

Primary Completion

August 9, 2019

Study Completion

August 31, 2019

Last Updated

September 16, 2019

Record last verified: 2019-09

Locations

US(1)