Predictive Value of Embryonic Testing

Completed

Conditions studied: Infertility

In brief

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.

Key facts

Study ID

NCT03604107

Run by

Reproductive Medicine Associates of New Jersey

People needed

237

Starts

2018-07-30

Expected to finish

2020-12-01

Last updated by the study team

2022-01-14

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Reproductive Medicine Associates of Florida — Lake Mary, Florida, United States
• Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States
• Reproductive Medicine Associates of Pennsylvania — Allentown, Pennsylvania, United States
• Reproductive Medicine Associates of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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