Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

Paused · Phase 2

Conditions studied: Infertility, Recurrent Pregnancy Loss

In brief

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.

Key facts

Study ID

NCT01546350

Run by

Reprogenetics

People needed

200

Starts

2012-03-01

Expected to finish

2014-06-01

Last updated by the study team

2013-08-21

Who can join

Age: 32 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Maternal age 33 to 42 years old (included)

You may not qualify if…

• 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.

Where it is running

• Southern California Reproductive Center — Beverly Hills, California, United States
• Reproductive Associates of Illinois — Highland Park, Illinois, United States
• Reprogenetics — Livingston, New Jersey, United States
• Long Island IVF — Melville, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.