Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

Reprogenetics

Status and phase: Suspended; Phase 2

Conditions: Recurrent Pregnancy Loss; Infertility

Treatments: Procedure: PGD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01546350

Reprogenetics study 389 (Other Identifier)

Details and patient eligibility

About

The investigators propose to perform a clinical randomized trial to evaluate the effect of single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete chromosome complement of the blastocyst in comparison to standard ART methods in which one or more embryo are replaced. Patients will be randomized into two groups:

• Control group: patients will have up to two embryos replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. If patients in the control group do not have a pregnancy to term from that fresh cycle, they will be offered free PGD either for the frozen embryos of that cycle or for the next cycle (up to the center and patient). Data from that PGD is not part of the study.
• Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Full description

Patients will be randomized after fertilization, and will be dropped from the study if they produce 3 or less blastocysts on day 5. The Primary efficacy endpoint of comparing the study group with the control will be (I) implantation rates and (II) multiple pregnancies (twin or higher order) comparing the first transfer.

The study may be extended to evaluate secondary efficacy endpoints which will be miscarriage rate and take home baby rates comparing the two groups.

Enrollment: 200 estimated patients

Sex: Female

Ages: 32 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Maternal age 33 to 42 years old (included)

Exclusion criteria

• MESA and TESE patients
• At least one partner carrier of a chromosomal or genetic disease
• Abnormal ovarian reserve, defined as FSH of >10 IU/L on day 2-4 of the cycle and AMH < 1ng /ml (If only one of the two parameters altered then patients is acceptable).
• Egg donor cycle (sperm donor is acceptable)

Exclusion criteria during stimulation:

• Less than eight antral follicles on day 2-4 of cycle

Exclusion criteria on day 5 post retrieval:

• Patients will be excluded if they produce less than 3 grade A,B or C blastocysts by day 5.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

Control - regular ART treatment

No Intervention group

Description:

patients will have up to two embryos replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. If patients in the control group do not have a pregnancy to term from that fresh cycle, they will be offered free PGD either for the frozen embryos of that cycle or for the next cycle (up to the center and patient). Data from that PGD is not part of the study.

Test - PGD

Experimental group

Description:

patients will have grade A,B or C blastocysts hatched on day 5, biopsied on day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Treatment:

Procedure: PGD

Procedure: PGD