Evaluation of Fetal Sex in Assisted Reproductive Technology (ART) Achieved Pregnancies (PREVIEW)
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Purpose
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.
| Condition |
|---|
|
Fetal Sex Determination |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Evaluation Of A Fetal Sex Determination Test At 36-56 Days Gestation In Assisted Reproductive Technology (ART) Achieved Pregnancies |
- Develop a prenatal sex test using blood and/or urine samples from pregnant women. [ Time Frame: 36 to 56 days of gestation ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Maternal whole blood and urine will be collected. Whole blood will be processed to plasma and buffy coat.
| Estimated Enrollment: | 500 |
| Study Start Date: | April 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Pregnant women
Pregnant women who have conceived via ART and are between days 36 and 56 of gestation
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Women who are pregnant via assisted reproductive technology between days 36 and 56 gestational age
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Contacts and Locations| United States, California | |
| San Diego Fertility Center | |
| San Diego, California, United States, 92130 | |
| United States, Illinois | |
| Fertility Centers of Illinois | |
| Glenview, Illinois, United States, 60026 | |
| United States, Nevada | |
| Fertility Center of Las Vegas | |
| Las Vegas, Nevada, United States, 89117 | |
| Study Director: | Allan Bombard, MD MBA | Sequenom, Inc. |
More Information
No publications provided
| Responsible Party: | Sequenom, Inc. |
| ClinicalTrials.gov Identifier: | NCT01021085 History of Changes |
| Other Study ID Numbers: | SQNM-IVF-FS-102 |
| Study First Received: | October 29, 2009 |
| Last Updated: | September 1, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Sequenom, Inc.:
|
Assisted Reproductive Technology circulating cell free fetal DNA First trimester |
ClinicalTrials.gov processed this record on May 16, 2013