Predictive Value of Embryonic Testing

Completed

• Conditions: Infertility

• Registration Number: NCT03604107
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

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).

Study Timeline

• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-07-19
• Study First Posted: 2018-07-27
• Study Start: 2018-07-30
• Primary Completion: 2020-09-30
• Study Completion: 2020-12-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-13
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 237

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive Value of Aneuploidy Screening	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.

Trial Locations

Locations (4)

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 Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Reproductive Medicine Associates of Pennsylvania; 🇺🇸 Allentown, Pennsylvania, United States