Spontaneous MiscarriageNICAEANCT05900076
Technical Feasibility of the cfDNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray
An observational study of Spontaneous Miscarriage, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Among the 15% of couples who experience a spontaneous early miscarriage (SEM) during their pregnancy, approximately 2 to 5% will suffer from recurrent SEM. It is only after the third SM that they will be offered a workup to look for a predisposition to SEM. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spontaneous Miscarriage
- What is being tested?
- Curettage for the evacuation of the product of conception
- How many people
- 78 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Jul 2023to 19 Jul 2024
- Phase
- Observational
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 15% of couples will experience spontaneous miscarriage during their reproductive life. Women that will go to the ObGyn Emergency Department of our Hospital where spontaneous miscarriage will be confirmed and curettage decided will be eligible for inclusion. No additional criterion applies.
Who may be able to join
- Patient who has suffered a miscarriage and requires a curettage to collect the product of conception
- Patient consenting to constitutional cytogenetic analysis on cfDNA and product of conception
- Patient of legal age
- Patient affiliated to a Social Security system.
Who cannot join
- Venous sampling impossible
- Miscarriage before 8 weeks of pregnancy (unusable cfDNA)
- Patient does not understand French
- Patient under legal protection
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hopital Femme-Mère-Enfant; service gynécologie/obstétrique
Bron, Rhône, 69500
Hopital Femme-Mère-Enfant; service médecine de la reproduction
Bron, Rhône, 69500
About this study
Official title: Technical Feasibility of the Cell-free DNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray
Among the 15% of couples who experience a spontaneous early miscarriage (SEM) during their pregnancy, approximately 2 to 5% will suffer from recurrent SEM. It is only after the third SM that they will be offered a workup to look for a predisposition to SEM. This workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event. These anomalies are responsible for approximately 50% of SEM and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup. The diagnosis of chromosomal abnormalities can be made by karyotype analysis or by Cytogenetic Microarray Analysis (CMA) on the product of conception. Unfortunately, karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity. The CMA is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination.
The study of cell-free DNA of syncytiotrophoblastic origin (cfDNA) circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21. cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus, can be easily obtained by maternal venous sampling. If maternal blood sampling is performed before complete removal of the product of conception, then detection of foetal chromosomal abnormalities would be possible. Thus, if failure rates of CMA and cfDNA techniques are comparable, cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained.
This study therefore proposes to compare the failure rates of the two technologies (CMA and cfDNA) for the detection of chromosomal abnormalities in recurrent SEM.
- Conditions
- Spontaneous Miscarriage
- Being tested
- Curettage for the evacuation of the product of conception
- Keywords
- Cell-free DNA, spontaneous miscarriage, chromosomal abnormalities, cytogenetic analysis
- Medical subject headings
- Chromosome Aberrations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curettage for the evacuation of the product of conceptionDiagnostic test
The product of conception taken during the intervention will be recovered at Day 1
| Study group | Role | What they receive |
|---|---|---|
| Patient group | This group corresponds to patients who have just suffered a miscarriage and are undergoing curettage for the evacuation of the product of conception. Receives: Diagnostic Test: Curettage for the evacuation of the product of conception |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure rate of cfDNA compared to CMA
Failure rate of cfDNA compared to CMA Since the difference in failure rates between the two techniques (MCA and cfDNA) corresponds to a comparison of 2 proportions in a matched situation.
Measured: The outcome measure (failure rates of both techniques) will be assessed through study completion ; estimated 6 months after last inclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start18 Jul 2023
- Primary completion19 Jul 2024
- Study completion19 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous MiscarriageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05900076
- Sponsor's protocol ID
- 69HCL21_0080
- Acronym
- NICAEA
- Status last verified
- Sep 2024
- First submitted
- 2 Jun 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Feasibility of the Cell-free DNA Test for Non-invasive Cytogenetic Analysis of Early Miscarriages Versus the Gold Standard Microarray
- ClinicalTrials.gov ID
- NCT05900076
- Acronym / sponsor ID
- NICAEA / 69HCL21_0080
- Conditions
- Spontaneous Miscarriage
- Keywords
- Cell-free DNA, spontaneous miscarriage, chromosomal abnormalities, cytogenetic analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 19 Jul 2024 (actual)
- First posted
- 12 Jun 2023 (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.
Among the 15% of couples who experience a spontaneous early miscarriage (SEM) during their pregnancy, approximately 2 to 5% will suffer from recurrent SEM. It is only after the third SM that they will be offered a workup to look for a predisposition to SEM. This workup does not currently include a search for foetal chromosomal abnormalities that could be considered causal for this event. These anomalies are responsible for approximately 50% of SEM and their detection could lead to an explanation for half of the couples currently without a diagnosis after a standard workup. The diagnosis of chromosomal abnormalities can be made by karyotype analysis or by Cytogenetic Microarray Analysis (CMA) on the product of conception. Unfortunately, karyotyping has a high failure rate due to poor cell culture of samples that are often degraded or of low quantity. The CMA is not always feasible due to the absence of analyzable feto-placental material linked to the use of a drug strategy for its elimination.
The study of cell-free DNA of syncytiotrophoblastic origin (cfDNA) circulating in the maternal plasma could be a solution as it is for non-invasive prenatal screening of trisomy 21. cfDNA is detectable from 6 to 8 weeks of amenorrhea and released in the maternal blood as long as placental tissue is present in the uterus, can be easily obtained by maternal venous sampling. If maternal blood sampling is performed before complete removal of the product of conception, then detection of foetal chromosomal abnormalities would be possible. Thus, if failure rates of CMA and cfDNA techniques are comparable, cfDNA could be preferred as it applies for miscarriages for whom no fetoplacental material can be obtained.
This study therefore proposes to compare the failure rates of the two technologies (CMA and cfDNA) for the detection of chromosomal abnormalities in recurrent SEM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Diagnostic Test: Curettage for the evacuation of the product of conceptionThis group corresponds to patients who have just suffered a miscarriage and are undergoing curettage for the evacuation of the product of conception. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15% of couples will experience spontaneous miscarriage during their reproductive life. Women that will go to the ObGyn Emergency Department of our Hospital where spontaneous miscarriage will be confirmed and curettage decided will be eligible for inclusion. No additional criterion applies.
Key inclusion criteria (4 listed)
- Patient who has suffered a miscarriage and requires a curettage to collect the product of conception
- Patient consenting to constitutional cytogenetic analysis on cfDNA and product of conception
- Patient of legal age
- Patient affiliated to a Social Security system.
Key exclusion criteria (4 listed)
- Venous sampling impossible
- Miscarriage before 8 weeks of pregnancy (unusable cfDNA)
- Patient does not understand French
- Patient under legal protection
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 |
|---|---|---|
| Curettage for the evacuation of the product of conceptionThe product of conception taken during the intervention will be recovered at Day 1 | Diagnostic test | Patient group |
Primary outcome
Failure rate of cfDNA compared to CMA
Time frame: The outcome measure (failure rates of both techniques) will be assessed through study completion ; estimated 6 months after last inclusion.
Failure rate of cfDNA compared to CMA Since the difference in failure rates between the two techniques (MCA and cfDNA) corresponds to a comparison of 2 proportions in a matched situation.
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 20 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Spontaneous Miscarriage
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
Not yet recruitingPhase 3
Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss
Early Pregnancy Loss
Recruiting
GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Miscarriage, run by Hospices Civils de Lyon at 2 sites in France.
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 4 inclusion and 4 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 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Failure rate of cfDNA compared to CMA (time frame: The outcome measure (failure rates of both techniques) will be assessed through study completion ; estimated 6 months after last inclusion.). 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 20 Sep 2024.