CompletedNot Applicable

Microchimerism in Patients With Recurrent Pregnancy Losses

Denmark32 participantsStarted 2022-04-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

sRPL patient (proband): Inclusion Criteria: * ≥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. Exclusion Criteria: * 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: Inclusion Criteria: * Age difference between proband and the older brother \<15 years * Common mother with the proband sRPL patient's child: Inclusion Criteria: * Age \<15 years

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Frequency of sRPL patients with microchimeric male cells

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

Frequency of sRPL patients with microchimeric cell originating from older brother

Timeframe: 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

Timeframe: 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

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

Frequency of sRPL patients with microchimeric cell originating from unknown person

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

Trial details

NCT IDNCT05340556

SponsorCaroline Nørgaard-Pedersen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-05

View on ClinicalTrials.gov More Recurrent Pregnancy Loss, Not Pregnant trials