Fetal Sex DeterminationNCT00970047
Development of a Fetal Sex Assay From Maternal Whole Blood
An observational study of Fetal Sex Determination, run by Sequenom, Inc. at 3 sites in United States.
Trial summary
Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Fetal Sex Determination
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jul 2010
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women between 6 and 16 weeks of gestation.
Who may be able to join
- Subject is 18-64 years of age
- Subject is female
- Subject is pregnant and between 6 and 16 weeks of gestation
- Subject provides a signed and dated informed consent
- If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
- If subject undergoes an invasive procedure, she agrees to provide the fetal sex results
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NCOG Medical Group
San Diego, California, 92037
IGO
San Diego, California, 92121
Scripps Clinic Medial Group
San Diego, California, 92128
About this study
Official title: Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation
Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.
Read the detailed description
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.
- Conditions
- Fetal Sex Determination
- Keywords
- pregnant, fetal sex determination, gender determination, noninvasive test, fetal DNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant females | Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startJun 2008
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Sex DeterminationStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Allan Bombard, MD, MBA, Study director, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970047
- Sponsor's protocol ID
- SQNM-FS-101
- Status last verified
- Oct 2009
- First submitted
- 31 Aug 2009
- Last updated
- 2 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Noninvasive Fetal Sex Determination Test Between 6 and 16 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT00970047
- Acronym / sponsor ID
- SQNM-FS-101
- Conditions
- Fetal Sex Determination
- Keywords
- pregnant, fetal sex determination, gender determination, noninvasive test, fetal DNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 2 Sep 2009 (estimated)
- 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.
Whole blood from pregnant women will be collected to develop a noninvasive fetal sex test.
Detailed description
This is an observational study whereby samples will be tested to determine the presence or absence of fetal Y chromosome genes to test for the fetal sex of the baby. The blood draw will occur between 6 to 16 weeks of gestation. The fetal gender will be requested at or soon after delivery if fetal sex was not previously obtained by CVS or amniocentesis genetic analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant females | – | –Women who are pregnant and between 6 and 16 weeks of gestation and who are 18 to 64 years of age. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women between 6 and 16 weeks of gestation.
Key inclusion criteria (6 listed)
- Subject is 18-64 years of age
- Subject is female
- Subject is pregnant and between 6 and 16 weeks of gestation
- Subject provides a signed and dated informed consent
- If subject undergoes a routine ultrasound between weeks 16 and 28, she agrees to provide the fetal sex results
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 2 Feb 2011.
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.
Allan Bombard, MD, MBA study director
Sequenom, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Sex Determination, run by Sequenom, Inc. at 3 sites 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 6 inclusion and 1 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 2 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 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.
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 2 Feb 2011.