Next Generation Sequencing Screening for Embryonic Ploidy Status (nexgen)

Reproductive Medicine Associates of New Jersey

Status: Completed

Conditions: Infertility

Treatments: Other: Comprehensive Chromosome Screening; Other: Morphologically Best

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02032264

RMA-2013-04

Details and patient eligibility

About

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.

Enrollment: 309 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 2 patient groups, including a placebo group

Comprehensive Chromosome Screening

Experimental group

Description:

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

Treatment:

Other: Comprehensive Chromosome Screening

No Comprehensive Chromosome Screening

Placebo Comparator group

Description:

The patients in this group will proceed with a single or double embryo transfer of the one or two morphologically best embryos.

Treatment:

Other: Morphologically Best