Fetal Sex DeterminationPREVIEWNCT01021085
Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies
An observational study of Fetal Sex Determination, run by Sequenom, Inc. at 3 sites in United States.
Trial summary
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Sex Determination
- How many people
- 500 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2009to Sep 2011
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age
Who may be able to join
- Subject is 18-45 years of age inclusive
- Subject is female
- Subject is pregnant
- Gestational age can be determined via IVF or IUI
- Subject is 36-42 days pregnant as determined by IVF transfer or IUI
- Subject agrees to provide 3 separate blood and urine samples
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fertility Centers of Illinois
Glenview, Illinois, 60026
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117
San Diego Fertility Center
San Diego, California, 92130
About this study
Official title: Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies
Whole blood and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.
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 and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.
- Conditions
- Fetal Sex Determination
- Keywords
- Assisted Reproductive Technology, circulating cell free fetal DNA, First trimester
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 women | Pregnant women who have conceived via ART and are between days 36 and 56 of gestation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a prenatal sex test using blood and/or urine samples from pregnant women.
Measured: 36 to 56 days of gestation
Secondary outcomes (1)
Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.
Measured: 36 to 56 days of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2011
- Study completionSep 2011
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allan Bombard, MD MBA, Study director, Sequenom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021085
- Sponsor's protocol ID
- SQNM-IVF-FS-102
- Acronym
- PREVIEW
- Status last verified
- Sep 2011
- First submitted
- 29 Oct 2009
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies
- ClinicalTrials.gov ID
- NCT01021085
- Acronym / sponsor ID
- PREVIEW / SQNM-IVF-FS-102
- Conditions
- Fetal Sex Determination
- Keywords
- Assisted Reproductive Technology, circulating cell free fetal DNA, First trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Nov 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 and urine samples will be collected from pregnant woman of gestational age 36-56 days as confirmed by artificial reproductive technology (ART). The samples will be used to develop a prenatal sex test using circulating cell free fetal DNA (ccffDNA) in maternal plasma or urine.
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 and urine collection will occur between 36-42, 43-49, and 50-56 days gestation. The fetal gender will be requested at or soon after delivery. The accuracy of the test and the optimal time to perform the test during pregnancy will be assessed by comparing the test results from maternal blood and/or urine samples obtained between days 36 and 56 of gestation to the fetal sex results obtained at birth.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women | – | –Pregnant women who have conceived via ART and are between days 36 and 56 of gestation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age
Key inclusion criteria (6 listed)
- Subject is 18-45 years of age inclusive
- Subject is female
- Subject is pregnant
- Gestational age can be determined via IVF or IUI
- Subject is 36-42 days pregnant as determined by IVF transfer or IUI
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
Develop a prenatal sex test using blood and/or urine samples from pregnant women.
Time frame: 36 to 56 days of gestation
1 secondary outcome
Establish the earliest time point between days 36 and 56 of gestation that the prenatal sex test has optimal performance.
Time frame: 36 to 56 days of gestation
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 5 Sep 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 5 Sep 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.
What does the primary outcome measure?
Develop a prenatal sex test using blood and/or urine samples from pregnant women. (time frame: 36 to 56 days of gestation). 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 5 Sep 2011.