Comparison of Standard ART Practice vs. Trophectoderm Biopsy, Array CGH Analysis, and Day-6 Replacement of a Single Euploid Embryo
Trial Snapshot
- Phase
- Phase 2
- Status
- Suspended
- Sponsor
- Reprogenetics
- Enrollment
- 200
- Locations
- 8
- Primary Endpoint
- Implantation rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 32 Years to 42 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Implantation rate
Time Frame: First month after replacement
fetal sacs / embryos replaced
Secondary Outcomes
- Spontaneous miscarriage rate(during first and second trimester of pregnancy)
- ongoing pregnancy rate(third trimester of pregnancy)
- Multiple pregnancy rate(first month after transfer)