Predictive Value of Embryonic Testing



Status:Recruiting
Conditions:Women's Studies, Infertility
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 42
Updated:8/5/2018
Start Date:July 30, 2018
End Date:September 2021
Contact:Christine V Whitehead, BSN, RN
Email:clinicalresearchteam@ivirma.com
Phone:973-656-2841

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Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles

The primary objective of this study is to determine the predictive value of preimplantation
genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to
define the related or independent predictive values of other proposed markers of embryonic
and maternal reproductive competence in assisted reproductive technology (ART) cycles.

Patients participating in the study will undergo a routine in vitro fertilization cycle.
Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be
analyzed till the clinical outcome has been determined. The single, morphologically best
embryo available will be selected for transfer. All clinical and laboratory care is identical
to that of which subjects would receive if they were not participating in the study. This
includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo
transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).

Inclusion Criteria:

1. Couples electing embryonic aneuploidy screening (PGS)

2. Couples electing single embryo transfer

Exclusion Criteria:

1. Any prior failed IVF cycle

2. Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness
≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance),
persistent endometrial fluid

3. Diagnosis of chronic endometritis

4. Maximum day 3 FSH level of 12 or higher

5. Anti-mullerian hormone level less than 1.0 g/mL, tested within previous year

6. Total basal antral follicle count less than 8 follicles

7. Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is
acceptable)

8. BMI <18.5 or > 35

9. Personal history of recurrent pregnancy loss (two or more pregnancy losses)

10. Use of oocyte donation

11. Use of gestational carrier

12. Medical condition predisposing patient to high risk pregnancy

13. Use of surgical procedures to obtain sperm

14. Presence of hydrosalpinges that communicate with endometrial cavity

15. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation

16. Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic
genetic analysis
We found this trial at
4
sites
Basking Ridge, New Jersey 07960
Principal Investigator: Richard T Scott, MD, HCLD
Phone: 973-656-2841
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Basking Ridge, NJ
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Allentown, Pennsylvania 18104
Principal Investigator: Richard T Scott, MD, HCLD
Phone: 973-656-2841
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Allentown, PA
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Lake Mary, Florida 32746
Principal Investigator: George Patounakis, MD, PhD
Phone: 973-656-2841
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Lake Mary, FL
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Philadelphia, Pennsylvania 19107
Principal Investigator: Jacqueline N Gutmann, MD
Phone: 973-656-2841
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Philadelphia, PA
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