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 |
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.
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).
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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Allentown, Pennsylvania 18104
Principal Investigator: Richard T Scott, MD, HCLD
Phone: 973-656-2841
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Lake Mary, Florida 32746
Principal Investigator: George Patounakis, MD, PhD
Phone: 973-656-2841
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Philadelphia, Pennsylvania 19107
Principal Investigator: Jacqueline N Gutmann, MD
Phone: 973-656-2841
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