Predictive Value of Embryonic Testing

Infertility Clinical Trial

— PROV-ET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03604107
• Other study ID #: RMA-2018-01
• Status: Completed
• Start date: July 30, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2022
• Source: Reproductive Medicine Associates of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: December 1, 2020
• Est. primary completion date: September 30, 2020
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Genetic:
• Preimplantation Genetic Testing-Aneuploidy
trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined

Locations

Country	Name	City	State
United States	Reproductive Medicine Associates of Pennsylvania	Allentown	Pennsylvania
United States	Reproductive Medicine Associates of New Jersey	Basking Ridge	New Jersey
United States	Reproductive Medicine Associates of Florida	Lake Mary	Florida
United States	Reproductive Medicine Associates of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Reproductive Medicine Associates of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive Value of Aneuploidy Screening	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.	approximately 1 month post clinical outcome