Next Generation Sequencing Screening for Embryonic Ploidy Status

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Comprehensive Chromosome Screening

Intervention Type OTHER

On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.

No Comprehensive Chromosome Screening

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

Group Type PLACEBO_COMPARATOR

Morphologically Best

Intervention Type OTHER

Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred

Interventions

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Comprehensive Chromosome Screening

On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.

Intervention Type OTHER

Morphologically Best

Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred

Intervention Type OTHER

Other Intervention Names

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PGD CCS Unscreened No CCS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No