Chorionic Villi DNA Methylation-Based Biomarkers in Patients With First Trimester Intrauterine Pregnancies

Overview

About this study

The purpose of this study is to Identify biomarkers for intrauterine pregnancy by determining differentially methylated DNA patterns in first trimester intrauterine chorionic villi samples.

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 - normal first trimester pregnancy tampon group: 

  • Viable intrauterine pregnancy on ultrasound.
  • < 15 weeks gestation.

Inclusion Criteria - surgical D&C group:

  • Confirmed non-viable missed miscarriage or incomplete miscarriage (also termed missed abortion/incomplete abortion) and planned dilation and curettage or manual vacuum aspiration procedure to remove contents.

Inclusion Criteria - ectopic/suspected ectopic with pregnancy of unknown location:

  • Clinician identification of suspicious adnexal mass OR abnormally trending hcg level with clinician suspicion for ectopic pregnancy OR surgical listing for ectopic pregnancy.

Inclusion Criteria - control hysterectomy group:

  • Age ≤ 42 years undergoing hysterectomy with salpingectomy for prolapse, dysmenorrhea, pelvic pain, non-submucosal fibroids, endometriosis, or gender dysphoria.

Inclusion Criteria - whole peripheral blood group:

  • Reproductive age (Age ≤ 42 years), female biologic sex. This group has been previously recruited, samples have been obtained, and is for comparison only.

Exclusion Criteria: 

  • Not pregnant.
  • Submucosal myoma, current known endometrial pathology (polyp, EIN), IUD in place in preceding month, cervical dysplasia.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/6/23. Questions regarding updates should be directed to the study team contact.

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alyssa Larish, M.D.

Open for enrollment

Contact information:

Alyssa Larish M.D.

(651) 267-5599

Larish.Alyssa@mayo.edu

More information

Publications

Publications are currently not available