Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Array CGH Analysis, and Day-6 Replacement of a Single Euploid Embryo

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01546350

Enrollment

200

Registered

2012-03-07

Start date

2012-03-31

Completion date

2014-06-30

Last updated

2013-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Recurrent Pregnancy Loss

Keywords

infertility, recurrent pregnancy loss, miscarriage

Brief summary

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.

Detailed 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.

Interventions

GENETICPGD

array CGH after blastocyst biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

32 Years to 42 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Implantation rate	First month after replacement	fetal sacs / embryos replaced

Secondary

Measure	Time frame	Description
Spontaneous miscarriage rate	during first and second trimester of pregnancy	pregnancies lost / pregnancies of cycles randomized
ongoing pregnancy rate	third trimester of pregnancy	pregnancies past second trimester / cycles started
Multiple pregnancy rate	first month after transfer	Twin or multiple order pregnancies / total pregnancies

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026