Noninvasive Preimplantation Genetic Testing for Aneuploidy

ICSI Clinical Trial

Official title:

Noninvasive Preimplantation Genetic Testing for Aneuploidy Using Cell Free DNA on Spent Culture Media

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04490889
• Other study ID #: CS/BVMÐ/20/11
• Status: Recruiting
• Start date: August 15, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: September 2020
• Source: M? Ð?c Hospital
• Contact: Dang V Vinh
• Phone: +840908225481
• Email: bsvinh.dq[@]myduchospital.vn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: November 30, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneuploidy
• ICSI
• Preimplantation Genetic Testing (PGT)

Intervention

Diagnostic Test:
• NiPGT-A
NiPGT-A is the technique to screen the aneuploidy status of an embryo without invasion technique, such as biopsy. We use SCM to isolate cfDNA, then amplify and analyse the aneuploidy of embryo secreting this material using NGS technique.

Locations

Country	Name	City	State
Vietnam	My Duc Hospital	Ho Chi Minh City
Vietnam	My Duc Phu Nhuan Hospital	Ho Chi Minh City	Phu Nhuan

Sponsors (2)

Lead Sponsor	Collaborator
M? Ð?c Hospital	My Duc Phu Nhuan Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of NiPGT-A	The ability to detect euploid embryo	4 months after recruiting
Primary	Specificity of NiPGT-A	The ability to detect aneuploid embryo	4 months after recruiting
Secondary	Successful amplification rate	Rate of SCM samples with DNA concentration after WGA greater than or equal 1ng/µl	7 days after SCM collection
Secondary	Total concordance	The match NGS results from TE biopsy and SCM for ploidy and sex	14 days after SCM collection
Secondary	Positive pregnancy rate	Rate of participants with serum human chorionic gonadotropin level greater than 25 mIU/mL	at 2 weeks after embryo transfer
Secondary	Clinical pregnancy rate	Rate of participants with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity.	5 weeks after embryo transfer
Secondary	Ongoing pregnancy rate	Rate of participants with detectable heart at 12 weeks' gestation or beyond, after the completion of the first transfer	At 12 weeks' gestation
Secondary	Implantation rate	as the number of gestational sacs per number of embryos transferred	3 weeks after embryo transfer