Recurrent Pregnancy Loss, Not PregnantNCT05340556
Microchimerism in Patients With Recurrent Pregnancy Losses
A study testing Blood sample and Swap test in people with Recurrent Pregnancy Loss, Not Pregnant, run by Caroline Nørgaard-Pedersen at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Pregnancy Loss, Not Pregnant
- What is being tested?
- Blood sample and Swap test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2022to 5 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥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.
- Age difference between proband and the older brother <15 years
- Common mother with the proband
- sRPL patient's child:
- Age <15 years
Who cannot join
- 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:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microchimerism From a Firstborn Boy or an Older Brother in Patients With Recurrent Pregnancy Losses: a Pilot Study
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.
Read the detailed description
To the investigators' knowledge, no previous study has determined the origin of microchimeric cells, and therefore, this pilot study will use a newly developed genetic analysis which will compare DNA fragments from the male microchimeric cells with DNA fragments from the RPL patient's son(s) and older brother(s).
The pilot study aims to evaluate the functions and capacity of a newly developed genetic test identifying microchimeric cells. A pilot study is necessary to assure the DNA fragments (indels) analyzed in the genetic analysis include enough informative differences to distinguish between the son(s), daughter(s) and the older brother(s) before these investigations can be initiated in a larger sample. To assure the test can distinguish origin of microchimeric cells between relatives and work independent of gender, The study will include both the proband's daughter(s) and son(s) to strengthen the confidence that the test possesses this ability.
10 sRPL and their older brother(s) and firstborn child is included. total included: approx 30.
Only sRPL whose brother(s) and child(ren) also consent to participate, will be included.
Blood sample of 12 ml EDTA plasma is collected from the sRPL patient. A swap sample from oral mucosa is collected from the older brother and child(ren).
The samples will be centrifuged and the buffy coat containing the DNA will be collected from patient and stored at -80 °C. To detect the multi-copy DYS14 marker located in the TSPY1 gene on the Y-chromosome a real-time PCR analysis will be performed on the extracted DNA with a PCR mastermix specific for the reference gene.
Also, The extracted DNA will be amplified using specific primers and their associated probes in a multiplex PCR analysis. The specific primers target the 10 different indels leading to 10 PCR products with non-overlapping amplicon sizes. After the PCR analyses, the fragments are analyzed by capillary electrophoresis using GeneticAnalyzer and GeneMapper. When differences are identified, a qPCR analysis is performed on samples from only the proband with primers and probes specific for the indel fragments that are only present in either the child or the older brother. 12 wells loaded with 30.000 GE in each well are screened along with a no-template control and a positive control containing 10 GE of DNA homozygous for the allele variant.
- Conditions
- Recurrent Pregnancy Loss, Not Pregnant
- Being tested
- Blood sample, Swap test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleGenetic
Blood sample of 12 ml EDTA plasma.
Swap testGenetic
receive swab tests for collecting cells from the oral mucosa
| Study group | Role | What they receive |
|---|---|---|
| sRPL patient | Experimental | sRPL with an older brother and at least one child prior to diagnosis Receives: 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 Receives: Genetic: Swap test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sRPL patients with microchimeric male cells
Prevalence of sRPL patients with microchimeric male cells in the peripheral blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Non-pregnant state, performed during study completion, i.e. within 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Apr 2022
- Primary completion5 Feb 2024
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy Loss, Not PregnantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caroline Nørgaard-Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital
- Responsible party
- Sponsor-investigator, Caroline Nørgaard-Pedersen, Aalborg University Hospital
- Investigators
- Caroline Nørgaard-Pedersen, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340556
- Sponsor's protocol ID
- F2022-012
- Status last verified
- Oct 2025
- First submitted
- 8 Apr 2022
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microchimerism From a Firstborn Boy or an Older Brother in Patients With Recurrent Pregnancy Losses: a Pilot Study
- ClinicalTrials.gov ID
- NCT05340556
- Acronym / sponsor ID
- F2022-012
- Conditions
- Recurrent Pregnancy Loss, Not Pregnant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Caroline Nørgaard-PedersenUniversity, hospital or other
- Collaborators
- Odense University Hospital, Aalborg University Hospital
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To the investigators' knowledge, no previous study has determined the origin of microchimeric cells, and therefore, this pilot study will use a newly developed genetic analysis which will compare DNA fragments from the male microchimeric cells with DNA fragments from the RPL patient's son(s) and older brother(s).
The pilot study aims to evaluate the functions and capacity of a newly developed genetic test identifying microchimeric cells. A pilot study is necessary to assure the DNA fragments (indels) analyzed in the genetic analysis include enough informative differences to distinguish between the son(s), daughter(s) and the older brother(s) before these investigations can be initiated in a larger sample. To assure the test can distinguish origin of microchimeric cells between relatives and work independent of gender, The study will include both the proband's daughter(s) and son(s) to strengthen the confidence that the test possesses this ability.
10 sRPL and their older brother(s) and firstborn child is included. total included: approx 30.
Only sRPL whose brother(s) and child(ren) also consent to participate, will be included.
Blood sample of 12 ml EDTA plasma is collected from the sRPL patient. A swap sample from oral mucosa is collected from the older brother and child(ren).
The samples will be centrifuged and the buffy coat containing the DNA will be collected from patient and stored at -80 °C. To detect the multi-copy DYS14 marker located in the TSPY1 gene on the Y-chromosome a real-time PCR analysis will be performed on the extracted DNA with a PCR mastermix specific for the reference gene.
Also, The extracted DNA will be amplified using specific primers and their associated probes in a multiplex PCR analysis. The specific primers target the 10 different indels leading to 10 PCR products with non-overlapping amplicon sizes. After the PCR analyses, the fragments are analyzed by capillary electrophoresis using GeneticAnalyzer and GeneMapper. When differences are identified, a qPCR analysis is performed on samples from only the proband with primers and probes specific for the indel fragments that are only present in either the child or the older brother. 12 wells loaded with 30.000 GE in each well are screened along with a no-template control and a positive control containing 10 GE of DNA homozygous for the allele variant.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sRPL patient | Experimental | Genetic: Blood samplesRPL with an older brother and at least one child prior to diagnosis |
| Brother or child to the sRPL patient | Experimental | Genetic: Swap testAn older brother (with at least same biological mother) og child to the sRPL patient |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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.
- Age difference between proband and the older brother <15 years
- Common mother with the proband
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleBlood sample of 12 ml EDTA plasma. | Genetic | sRPL patient |
| Swap testreceive swab tests for collecting cells from the oral mucosa | Genetic | Brother or child to the sRPL patient |
Primary outcome
Frequency of sRPL patients with microchimeric male cells
Time frame: Non-pregnant state, performed during study completion, i.e. within 1 year
Prevalence of sRPL patients with microchimeric male cells in the peripheral blood
Frequency of sRPL patients with microchimeric cell originating from older brother
Time frame: Non-pregnant state, performed during study completion, i.e. within 1 year
Determination of microchimeric cell origin: brother, son, daughter or not identified
Frequency of sRPL patients with microchimeric cell originating from the patient's son
Time frame: Non-pregnant state, performed during study completion, i.e. within 1 year
Determination of microchimeric cell origin: brother, son, daughter or not identified
Frequency of sRPL patients with microchimeric cell originating from the patient's daughter
Time frame: Non-pregnant state, performed during study completion, i.e. within 1 year
Determination of microchimeric cell origin: brother, son, daughter or not identified
Frequency of sRPL patients with microchimeric cell originating from unknown person
Time frame: Non-pregnant state, performed during study completion, i.e. within 1 year
Determination of microchimeric cell origin: brother, son, daughter or not identified
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Nørgaard-Pedersen, MD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample and Swap test in people with Recurrent Pregnancy Loss, Not Pregnant, run by Caroline Nørgaard-Pedersen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of sRPL patients with microchimeric male cells (time frame: Non-pregnant state, performed during study completion, i.e. within 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.