Microchimerism in Patients With Recurrent Pregnancy Losses

NCT05340556 | Completed

• 1 other identifier: F2022-012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to evaluate if microchimeric cells in a patient with recurrent pregnancy loss (RPL) can be detected by the blood analysis for the presence of the DYS14 gene and the use of indel-panel methods and also, to examine if this method can distinguish the cell's origin; comparing gene sequence from the patient's firstborn son or her older brother. In addition, the pilot study will provide the investigators with information and experience necessary for a subsequent main study to be conducted.

Conditions

Recurrent Pregnancy Loss, Not Pregnant

Outcome Measures

Primary Outcomes (5)

• Frequency of sRPL patients with microchimeric male cells

  Prevalence of sRPL patients with microchimeric male cells in the peripheral blood

  Non-pregnant state, performed during study completion, i.e. within 1 year

• Frequency of sRPL patients with microchimeric cell originating from older brother

  Determination of microchimeric cell origin: brother, son, daughter or not identified

  Non-pregnant state, performed during study completion, i.e. within 1 year

• Frequency of sRPL patients with microchimeric cell originating from the patient's son

  Determination of microchimeric cell origin: brother, son, daughter or not identified

  Non-pregnant state, performed during study completion, i.e. within 1 year

• Frequency of sRPL patients with microchimeric cell originating from the patient's daughter

  Determination of microchimeric cell origin: brother, son, daughter or not identified

  Non-pregnant state, performed during study completion, i.e. within 1 year

• Frequency of sRPL patients with microchimeric cell originating from unknown person

  Determination of microchimeric cell origin: brother, son, daughter or not identified

  Non-pregnant state, performed during study completion, i.e. within 1 year

Study Arms (2)

sRPL patient

EXPERIMENTAL

sRPL with an older brother and at least one child prior to diagnosis

Genetic: Blood sample

Brother or child to the sRPL patient

EXPERIMENTAL

An older brother (with at least same biological mother) og child to the sRPL patient

Genetic: Swap test

Interventions

Blood sample GENETIC

Blood sample of 12 ml EDTA plasma.

sRPL patient

Swap test GENETIC

receive swab tests for collecting cells from the oral mucosa

Brother or child to the sRPL patient

Eligibility Criteria

• Gender Eligibility Details: sRPL patient: women. Sibling: Older brother to sRPL patient. Child: The sRPL patient's child(ren) of both sexes. Biological sex is used.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥3 consecutive pregnancy losses ≤12 weeks of gestation, which do not include confirmed ectopic or molar pregnancies.
• Age \<41 years at time of admission
• Patients who have minimum one alive older brother with a common mother and prior birth of a boy, and patients who have minimum one alive older brother with a common mother and prior birth of a girl.

You may not qualify if:

• Significant intrauterine malformations
• Thyroid dysfunction
• Known chromosomal abnormality
• An older brother, a son or a daughter from whom we cannot not collect a swab test e.g., due to lack of consent, death, distance etc.
• Transplant recipient
• Transfusion recipient
• Pregnancy at the time the blood sample is collected
• Older Brother:
• Age difference between proband and the older brother \<15 years
• Common mother with the proband
• sRPL patient's child:
• Age \<15 years

Sponsors & Collaborators

• Caroline Nørgaard-Pedersen: lead
• Department of Clinical Immunology, Odense University Hospital, DK: collaborator
• Aalborg University Hospital: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

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

Study Officials

• Caroline Nørgaard-Pedersen, MD

  Aalborg University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 22, 2022
• Study Start: April 1, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-10

Locations

DK (1)