An observational study in Aneuploidy, Down Syndrome and Noninvasive Prenatal Screening, sponsored by Sequenom, Inc.. Completed at 27 sites in United States. Open to female participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2016-04-20.
Sponsored by Sequenom, Inc. (part of Labcorp) · Observational
Among 31 studies in Aneuploidy with a site in United States — 6 open to participants now, 8 under way, none of them phase 3. Aneuploidy · United States.
Among the 31 studies in Aneuploidy with a site in United States, this one is the 5th largest by enrollment of the 17 observational ones, is one of 3 that started in 2012, is one of 17 observational ones, and was the 10th registered.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's enrollment of 3,333 is above the median of 325 across 38 observational studies indexed under Aneuploidy.
Browse Aneuploidy studies →6 of the 31 studies in Aneuploidy with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 8 Aneuploidy studies recruiting now, 5 (63%) set no upper age limit and 3 (38%) stop at 75 or younger; 5 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 34 Years · female · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 3 started in 2012.
Median enrollment 202 across the 14 interventional studies, 2,000 across the 17 observational. Of the 20 that completed or were terminated, 3 (15%) have results posted.
18 of 31 have an industry lead sponsor. The 10 most frequent:
Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Sequenom, Inc. has 4 studies filed under Aneuploidy — fewer than ten, so there is no comparison to draw.
1 of the studies in Aneuploidy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07369362MotilityCount apsTo Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That Develop to the Point That They Are Able to be Transferred) in IVF Cycles. | 2027-03-20 |
Among the 31 studies in Aneuploidy with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled. Study blood will be collected in the first or second trimester at a scheduled prenatal screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will be followed until delivery and the birth outcome recorded.
Pregnant with low risk for fetal chromosome 21 aneuploidy
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: SEQureDx Trisomy Test
Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.
Estimate the false positive rate of SEQureDx Trisomy 21 Test
Time frame: pregnancy outcome
Plan to share: Yes — Upon analysis of collected samples and submission for publication, data will be shared as per journal requirements.
The record gives a start of Jul 2012, a primary completion of Feb 2014 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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