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OpenTrials
Completed

NCT Number: NCT03604107

Predictive Value of Embryonic Testing

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.

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Reproductive Medicine Associates of Florida, Lake Mary, Florida, United States

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About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Couples electing embryonic aneuploidy screening (PGS)
  • Couples electing single embryo transfer

Exclusion criteria

  • Any prior failed IVF cycle
  • Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
  • Diagnosis of chronic endometritis
  • Maximum day 3 FSH level of 12 or higher
  • Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
  • Total basal antral follicle count less than 8 follicles
  • Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
  • BMI <18.5 or > 35
  • Personal history of recurrent pregnancy loss (two or more pregnancy losses)
  • Use of oocyte donation
  • Use of gestational carrier
  • Medical condition predisposing patient to high risk pregnancy
  • Use of surgical procedures to obtain sperm
  • Presence of hydrosalpinges that communicate with endometrial cavity
  • Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
  • Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis

Treatment and study plan

Preimplantation Genetic Testing-Aneuploidy

Genetic

trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined

Primary outcomes

  1. Predictive Value of Aneuploidy Screening

    Time frame: approximately 1 month post clinical outcome

    Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes.

Sponsors and collaborators

Lead sponsor

Reproductive Medicine Associates of New Jersey

Other

Registry information

Official study title

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

Acronym: PROV-ET

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 27, 2018
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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