Next Generation Sequencing Screening for Embryonic Ploidy Status

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Comprehensive Chromosome Screening; Other: Morphologically Best

• Registration Number: NCT02032264
• Lead Sponsor: Reproductive Medicine Associates of New Jersey

Brief Summary

To evaluate the benefits of using next generation sequencing to assess embryonic aneuploidy. All viable blastocysts will be biopsied and cryopreserved for future transfer. After the final embryo is cryopreserved, patients will be randomized to either the intervention group or the control group. Patients and doctors are blinded to the randomization until study completion. A Double Embryo Transfer (DET) will be performed with either screened or unscreened embryos depending on randomization. A Single Embryo Transfer (SET) may occur in cases where only one embryo is available for transfer.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-09
• Study First Posted: 2014-01-10
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 309

Inclusion Criteria

• Patient undergoing IVF/CCS (no PGD banking)
• Patient meets ASRM guidelines for Double Embryo Transfer (DET)
• Donor Sperm OK
• AMH ≥ 1.2
• FSH ≤ 12
• BAFC ≥12
• Max 1 prior failed IVF cycle for patients 35-45 years old
• Patient <35 years old MUST have 1 prior failed IVF cycle

Exclusion Criteria

• Chronic endometrial insufficiency
• Use of oocyte donor or gestational carriers
• Medical contraindications to Double Embryo Transfer (DET)
• Male Factor (<100,000 sperm or surgical sperm)
• Communicating hydrosalpinx (on HSG)
• Single gene disorders or sex selection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive Chromosome Screening	Comprehensive Chromosome Screening	Trophectoderm biopsy will be performed on all blastocysts and CCS via next generation sequencing screening performed on biopsy samples. Patients will proceed with a single or double embryo transfer of the one or two morphologically best euploid embryos
No Comprehensive Chromosome Screening	Morphologically Best	The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.

Primary Outcome Measures

Name	Time	Method
Impact of next generation sequencing on the embryos produced from IVF on implantation rates	2 years	To evaluate the benefits, if any, of using next generation sequencing based Comprehensive Chromosome Screening (CCS) in the selection of embryos for transfer during clinical IVF cycles

Secondary Outcome Measures

Name	Time	Method
Delivery Rates	2 years

Trial Locations

Locations (1)

Reproductive Medicine Associates of New Jersey; 🇺🇸 Basking Ridge, New Jersey, United States