Measuring Immune Tolerance to Predict Miscarriage or Failed Embryo Transfer

NCT04156126 | Completed

• 1 other identifier: 18-011413
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnancy is a unique period which requires alterations in the immune system to allow for tolerance of a haploidentical fetus. The goal of this study is to measure maternal blood levels of proteins known to promote immune tolerance in early implantation and pregnancy to look for associations between tolerance, miscarriage and failed embryo transfer. Establishing predictive factors of miscarriage and failed in vitro fertilization could have implications for a large portion of couples and serve to guide current and future family planning efforts.

Conditions

Infertility; Pregnancy Loss; Spontaneous Abortion

Outcome Measures

Primary Outcomes (2)

• Spontaneous Conception Cohort: change in immune tolerance, as measured by Enzyme Linked Immunosorbent Assay (ELISA)

  Tolerance markers galectin-9, IL-4 and VEGF (-A,-B,-C,-D) will be measured for their concentration in maternal blood in women who conceived naturally, as determined by experimental standard curves.

  Baseline (6-12 weeks gestation)

• Infertility Cohort: change in immune tolerance, as measured by Enzyme Linked Immunosorbent Assay (ELISA)

  Tolerance markers galectin-9, IL-4 and VEGF (-A,-B,-C,-D) will be measured for their concentration in maternal blood in women who undergo embryo transfer, as determined by experimental standard curves.

  Change from baseline (day of transfer) at Day 11

Study Arms (2)

Infertility - Frozen Embryo Transfer

Adult females undergoing a frozen embryo transfer

Other: Blood Collection

Spontaneous Conception

Adult females presenting with positive pregnancy test to the Obstetrics Department

Other: Blood Collection

Interventions

Blood Collection OTHER

Blood Collection

Infertility - Frozen Embryo Transfer; Spontaneous Conception

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Females age 18 or older
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Females age 18 or older who are undergoing a frozen embryo transfer or have a confirmed intrauterine pregnancy between 5 0/7 weeks and 9 6/7 week gestation.

You may qualify if:

• Females, 18 years old or older
• Patients undergoing a frozen embryo transfer OR confirmed intrauterine pregnancy between 5 0/7 weeks and 9 6/7 weeks gestation
• Patients planning to have all bloodwork done at Mayo Clinic Rochester
• Patients planning to deliver at Mayo Clinic or within the Mayo Clinic Health Systems

You may not qualify if:

• Non English speaking
• Pregnancy with multiple fetuses
• Patient has non-viable pregnancy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

In cohort 1, 10mL blood samples will be drawn from subjects undergoing a frozen embryo transfer at 4 different time points. In cohort 2, 10mL blood samples will be drawn from subjects with spontaneous conception at 1 time point.

MeSH Terms

Conditions

Infertility; Abortion, Spontaneous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Chandra C Shenoy, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: November 7, 2019
• Study Start: August 23, 2019
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Locations

US (1)