Early Pregnancy LossNCT04935138
Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
An observational study of Early Pregnancy Loss, run by Quest Diagnostics-Nichols Insitute at 1 site in United States.
Trial summary
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Early Pregnancy Loss
- What is being tested?
- cfDNA analysis
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 31 Dec 2022
- 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 to 50 years
- Women only
- Adult
Study population: Previously pregnant women that have recently miscarried.
Who may be able to join
- 5-20 weeks of gestation by ultrasound
- Miscarriage diagnosed by ultrasound
- Pregnancy tissue still present in utero, including an empty sac, and not completely expelled
Who cannot join
- Maternal age < 18 years
- No visible pregnancy tissue on ultrasound
- Multiple fetal gestation (> than singleton)
- Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
- No microarray testing is planned on the product of conception
- Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
- Patient unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Quest Diagnostics
San Juan Capistrano, California, 92675
About this study
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.
- Conditions
- Early Pregnancy Loss
- Being tested
- cfDNA analysis
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cfDNA analysisGenetic
sequencing data from cfDNA analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
microarray analysis of products of conception (POC)
chromosome anomalies
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Why it stopped: Low participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Pregnancy LossStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quest Diagnostics-Nichols Insitute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illumina, Inc.
- Responsible party
- Sponsor
- Investigators
- Pranoot X Tanpaiboon, MD, Principal investigator, Quest Diagnostics-Nichols InsituteKaren E Racicot, PhD, Principal investigator, Quest Diagnostics-Nichols Insitute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935138
- Sponsor's protocol ID
- CD20-011
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Practice Committee of the American Society for Reproductive Medicine. Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012 Nov;98(5):1103-11. doi: 10.1016/j.fertnstert.2012.06.048. Epub 2012 Jul 24.
PubMed 22835448Barisic I, Zergollern L, Muzinic D, Hitrec V. Risk estimates for balanced reciprocal translocation carriers--prenatal diagnosis experience. Clin Genet. 1996 Mar;49(3):145-51. doi: 10.1111/j.1399-0004.1996.tb03274.x.
PubMed 8737980ESHRE. European Society of Human Reproduction and Embryology guideline: recurrent pregnancy loss. Human Reproduction Open 2018: 1-12.
Kutteh WH, Miller CE, Park JK, Corey V, Chavez M, Racicot K, Alagia DP 3rd, Jinnett KN, Curnow K, Dalton K, Bhatt S, Keefe DL. Cell-Free DNA Analysis of Fetal Aneuploidies in Early Pregnancy Loss. J Clin Med. 2024 Jul 23;13(15):4283. doi: 10.3390/jcm13154283.
PubMed 39124551
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
- ClinicalTrials.gov ID
- NCT04935138
- Acronym / sponsor ID
- CD20-011
- Conditions
- Early Pregnancy Loss
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low participation
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Quest Diagnostics-Nichols InsituteIndustry (pharma, biotech, devices)
- Collaborators
- Illumina, Inc.
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Jun 2021 (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.
The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Previously pregnant women that have recently miscarried.
Key inclusion criteria (3 listed)
- 5-20 weeks of gestation by ultrasound
- Miscarriage diagnosed by ultrasound
- Pregnancy tissue still present in utero, including an empty sac, and not completely expelled
Key exclusion criteria (7 listed)
- Maternal age < 18 years
- No visible pregnancy tissue on ultrasound
- Multiple fetal gestation (> than singleton)
- Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
- No microarray testing is planned on the product of conception
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 |
|---|---|---|
| cfDNA analysissequencing data from cfDNA analysis | Genetic | – |
Primary outcome
microarray analysis of products of conception (POC)
Time frame: 7 days
chromosome anomalies
Results and safety
The study was stopped early (reason given: Low participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 22835448Practice Committee of the American Society for Reproductive Medicine. Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012 Nov;98(5):1103-11. doi: 10.1016/j.fertnstert.2012.06.048. Epub 2012 Jul 24.
- Background: PubMed 8737980Barisic I, Zergollern L, Muzinic D, Hitrec V. Risk estimates for balanced reciprocal translocation carriers--prenatal diagnosis experience. Clin Genet. 1996 Mar;49(3):145-51. doi: 10.1111/j.1399-0004.1996.tb03274.x.
- BackgroundESHRE. European Society of Human Reproduction and Embryology guideline: recurrent pregnancy loss. Human Reproduction Open 2018: 1-12.
- Derived from this study: PubMed 39124551Kutteh WH, Miller CE, Park JK, Corey V, Chavez M, Racicot K, Alagia DP 3rd, Jinnett KN, Curnow K, Dalton K, Bhatt S, Keefe DL. Cell-Free DNA Analysis of Fetal Aneuploidies in Early Pregnancy Loss. J Clin Med. 2024 Jul 23;13(15):4283. doi: 10.3390/jcm13154283.
- Individual participant dataSharing planned: No
Related trials for Early Pregnancy Loss
Not yet recruiting
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
Early Pregnancy Loss, Procedural Pain
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingPhase 3
Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
Pregnancy Loss, Pregnancy Loss, Early
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Research on Equity in Abortion Care by TeleHealth
Abortion in First Trimester, Abortion Early
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.
Pranoot X Tanpaiboon, MD principal investigator
Quest Diagnostics-Nichols Insitute
Karen E Racicot, PhD principal investigator
Quest Diagnostics-Nichols Insitute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Pregnancy Loss, run by Quest Diagnostics-Nichols Insitute at 1 site in United States.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Dec 2023. 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 United States. 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 was stopped early (reason given: Low participation). Results are not available in the source record.
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?
microarray analysis of products of conception (POC) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04935138, which also lists 4 linked publications.
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 1 Dec 2023.