Noninvasive Preimplantation Genetic Testing for Aneuploidy

• Conditions: Preimplantation Genetic Testing (PGT); ICSI
• Interventions: Diagnostic Test: NiPGT-A

• Registration Number: NCT04490889
• Lead Sponsor: Mỹ Đức Hospital

Brief Summary

The study is conducted to evaluate the sensitivity and specificity of non-invasive preimplantation genetic testing for aneuploidy (NiPGT-A) using cell free DNA into spent culture medium (SCM).

Detailed Description

Our study is a diagnostic study, recruit 218 biopsied blastocysts from couples undergoing intracytoplasmic sperm injection (ICSI) with Preimplantation genetic testing for aneuploidy (PGT-A) or Preimplantation genetic testing for structural rearrangements (PGT-SR) indication.

Oocyte retrieval, ICSI and embryo culture are performed by routine protocol.

On day 3, each embryo was washed and cultured in single droplets. TE biopsy was conducted and 10μl SCM of biopsied embryos are collected on day 5 or day 6. Both sample types undergo whole-genome amplification (WGA) using Quanti Flour ONE dsDNA system and DNA analysis by next-generation sequencing (NGS) using NextSeq High output 150 cycles kit.

Comparison of NGS results from trophectoderm (TE) biopsy and SCM is done to identify the sensitivity and specificity of the test.

A sample size of 218 day 5/day 6 embryos will be needed.

Study Timeline

• Study First Submitted: 2020-07-24
• Study First Submitted QC: 2020-07-24
• Study First Posted: 2020-07-29
• Study Start: 2020-08-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-20
• Last Update Posted: 2020-09-22
• Primary Completion: 2020-10-31
• Study Completion: 2020-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• Assisted Reproductive Treatment with ICSI indication
• Having PGT-A or PGT-SR indication
• Having an agreement to be enrolled into NiPGT-A study
• Having blastocyst to biopsy

Exclusion Criteria

• In vitro maturation cycle

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with PGT indication	NiPGT-A	Patients undergo in vitro fertilization with PGT-A or for PGT-SR indication

Primary Outcome Measures

Name	Time	Method
Sensitivity of NiPGT-A	4 months after recruiting	The ability to detect euploid embryo
Specificity of NiPGT-A	4 months after recruiting	The ability to detect aneuploid embryo

Secondary Outcome Measures

Name	Time	Method
Total concordance	14 days after SCM collection	The match NGS results from TE biopsy and SCM for ploidy and sex
Ongoing pregnancy rate	At 12 weeks' gestation	Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer
Successful amplification rate	7 days after SCM collection	Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/μl
Positive pregnancy rate	at 2 weeks after embryo transfer	Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL
Clinical pregnancy rate	5 weeks after embryo transfer	Rate of participants with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity.
Implantation rate	3 weeks after embryo transfer	as the number of gestational sacs per number of embryos transferred

Trial Locations

Locations (2)

My Duc Phu Nhuan Hospital; 🇻🇳 Ho Chi Minh City, Phu Nhuan, Vietnam

My Duc Hospital; 🇻🇳 Ho Chi Minh City, Vietnam