Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing

Reprogenetics

Status and phase: Unknown; Phase 2

Conditions: Infertility

Treatments: Other: PGD

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02000349

Reprogenetics-3.117

Details and patient eligibility

About

The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).

Full description

1. Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
2. Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*).

(*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):

Enrollment: 186 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (pre-stimulation):

• Age up to 42 years

Exclusion Criteria (pre-stimulation):

• MESA and TESE patients
• At least one partner carrier of a chromosomal abnormality
• Egg donor cycle (sperm donor is acceptable)
• Gender selection cycles
• Thaw cycles
• Any patient who cannot have a fresh embryo transfer
• FSH above 12 or AMH less than 1

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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186 participants in 2 patient groups

Frozen Embryo Transfer with PGD

Experimental group

Description:

All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*).

Treatment:

Other: PGD

Fresh Embryo Transfer with PGD

Experimental group

Description:

All embryos will be hatched on day 3. Patients will have hatching blastocysts (\*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (\*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Treatment:

Other: PGD