Clinical trial NCT03604107: Predictive Value of Embryonic Testing
Official title: Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 237
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile couples attempting conception through in vitro fertilization

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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 0.5 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

Primary outcomes:
measure: Predictive Value of Aneuploidy Screening
timeFrame: approximately 1 month post clinical outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Mary
country: United States
facility: Reproductive Medicine Associates of Florida
state: Florida
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
city: Allentown
country: United States
facility: Reproductive Medicine Associates of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Reproductive Medicine Associates of Philadelphia
state: Pennsylvania
Study officials:
affiliation: IVI RMA
name: Richard T Scott Jr., MD, HCLD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.