A Study to Measure Markers of Immune Tolerance to Predict Women at Risk of Miscarriage or Failed Embryo Transfer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 18-011413
NCT ID: NCT04156126
Sponsor Protocol Number: 18-011413
About this study
The purpose of this study is:
Infertility Cohort - To determine if maternal blood concentrations of Gal-9, IL-4, and VEGF-A, -C, -D at the time of embryo transfer in patients undergoing in vitro fertilization are predictive of the cycle outcome: live birth or no live birth
Spontaneous Conception Cohort - To determine if maternal blood concentrations of Gal-9, IL-4, and VEGF-A, -C, -D early in the first trimester of gestation are predictive of miscarriage or live birth.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria - Infertility Cohort:
- Adult females undergoing a euploid frozen embryo transfer.
- Women age 18 years of age or older.
- Must be planning to have all blood work done at Mayo Clinic Rochester so we can receive the study samples.
- Must be planning to deliver within the Mayo Clinic Health System so that we can review pregnancy outcomes.
Exclusion Criteria - Infertility Cohort:
- Non English speaking.
- Less than 18 years of age.
- Planning follow-up outside Mayo Clinic Rochester/MCHS.
- Pregnancies with multiple fetuses.
Inclusion Criteria - Spontaneous Conception Cohort:
- Adult women presenting with positive pregnancy test to the Obstetrics Department.
- Women age 18 years of age or older.
- Confirmed intrauterine pregnancy (defined as gestational sac with yolk sac +/- fetal pole).
- Patients need to be planning to deliver within the Mayo Clinic Health System so that we can review pregnancy outcomes.
Exclusion Criteria - Spontaneous Conception Cohort:
- Non English speaking.
- Less than 18 years of age.
- Planning follow-up outside Mayo Clinic Rochester/MCHS.
- Patients desiring termination of pregnancy.
- Known miscarriage at the time of recruitment.
- Pregnancies with multiples.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Chandra Paff Shenoy, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available