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InfertilityPhase 2NCT01546350

Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH

A Phase 2 study testing PGD in people with Infertility and Recurrent Pregnancy Loss, run by Reprogenetics at 4 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 32 to 42 years, women only
Conditions the study is for
Infertility, Recurrent Pregnancy Loss
What is being tested?
PGD
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
4 sitesUnited States
Study dates
Mar 2012to Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 32 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Maternal age 33 to 42 years old (included)

Who cannot join

  • 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)
  • Less than eight antral follicles on day 2-4 of cycle
  • Patients will be excluded if they produce less than 3 grade A,B or C blastocysts by day 5.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Southern California Reproductive Center

    Beverly Hills, California, 92677

  • Reproductive Associates of Illinois

    Highland Park, Illinois, 60035

  • Reprogenetics

    Livingston, New Jersey, 07039

  • Long Island IVF

    Melville, New York, 11747

Other trials in United States

About this study

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

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.
Read the 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.

Being tested
PGD
Keywords
infertility, recurrent pregnancy loss, miscarriage
Medical subject headings
Infertility, Abortion, Spontaneous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PGDGenetic

    Also called PGD: Preimplantation Genetic Diagnosis

    array CGH after blastocyst biopsy

  • PGDProcedure or surgery

    PGD using blastocyst biopsy and testing of the biopsy by array CGH

Study groups in NCT01546350
Study groupRoleWhat they receive
Control - regular ART treatmentNo interventionpatients 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 - PGDExperimentalpatients 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.
Receives: Genetic: PGD; Procedure: PGD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Implantation rate

    fetal sacs / embryos replaced

    Measured: First month after replacement

Secondary outcomes (3)

  1. Spontaneous miscarriage rate

    pregnancies lost / pregnancies of cycles randomized

    Measured: during first and second trimester of pregnancy

  2. ongoing pregnancy rate

    pregnancies past second trimester / cycles started

    Measured: third trimester of pregnancy

  3. Multiple pregnancy rate

    Twin or multiple order pregnancies / total pregnancies

    Measured: first month after transfer

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2013 (estimated)
  4. Study completionJun 2014 (estimated)

Why it stopped: not enough patients recruited on time

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01546350
Sponsor's protocol ID
Reprogenetics study 389
Other IDs
Reprogenetics study 389
Status last verified
May 2013
First submitted
2 Mar 2012
Last updated
21 Aug 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Gutierrez-Mateo C, Colls P, Sanchez-Garcia J, Escudero T, Prates R, Ketterson K, Wells D, Munne S. Validation of microarray comparative genomic hybridization for comprehensive chromosome analysis of embryos. Fertil Steril. 2011 Mar 1;95(3):953-8. doi: 10.1016/j.fertnstert.2010.09.010. Epub 2010 Oct 25.

    PubMed 20971462

  • Cohen J, Wells D, Munne S. Removal of 2 cells from cleavage stage embryos is likely to reduce the efficacy of chromosomal tests that are used to enhance implantation rates. Fertil Steril. 2007 Mar;87(3):496-503. doi: 10.1016/j.fertnstert.2006.07.1516. Epub 2006 Dec 4.

    PubMed 17141767

  • Munne S, Wells D, Cohen J. Technology requirements for preimplantation genetic diagnosis to improve assisted reproduction outcomes. Fertil Steril. 2010 Jul;94(2):408-30. doi: 10.1016/j.fertnstert.2009.02.091. Epub 2009 May 5.

    PubMed 19409550

  • Schoolcraft WB, Fragouli E, Stevens J, Munne S, Katz-Jaffe MG, Wells D. Clinical application of comprehensive chromosomal screening at the blastocyst stage. Fertil Steril. 2010 Oct;94(5):1700-6. doi: 10.1016/j.fertnstert.2009.10.015. Epub 2009 Nov 25.

    PubMed 19939370

  • De Vos A, Staessen C, De Rycke M, Verpoest W, Haentjens P, Devroey P, Liebaers I, Van de Velde H. Impact of cleavage-stage embryo biopsy in view of PGD on human blastocyst implantation: a prospective cohort of single embryo transfers. Hum Reprod. 2009 Dec;24(12):2988-96. doi: 10.1093/humrep/dep251. Epub 2009 Sep 21.

    PubMed 19773223

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PGD in people with Infertility and Recurrent Pregnancy Loss, run by Reprogenetics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 21 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implantation rate (time frame: First month after replacement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01546350, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2013.

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