NCT01546350

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

4 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

August 21, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

March 2, 2012

Last Update Submit

August 20, 2013

Conditions

InfertilityRecurrent Pregnancy Loss

Keywords

infertility, recurrent pregnancy loss, miscarriage

Outcome Measures

Primary Outcomes (1)

  • Implantation rate

    fetal sacs / embryos replaced

    First month after replacement

Secondary Outcomes (3)

  • Spontaneous miscarriage rate

    during first and second trimester of pregnancy

  • ongoing pregnancy rate

    third trimester of pregnancy

  • Multiple pregnancy rate

    first month after transfer

Study Arms (2)

Control - regular ART treatment

NO INTERVENTION

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

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.

Genetic: PGDProcedure: PGD

Interventions

PGDGENETIC

array CGH after blastocyst biopsy

Also known as: PGD: Preimplantation Genetic Diagnosis
Test - PGD

Eligibility Criteria

Age32 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Southern California Reproductive Center

Beverly Hills, California, 92677, United States

Location

Reproductive Associates of Illinois

Highland Park, Illinois, 60035, United States

Location

Reprogenetics

Livingston, New Jersey, 07039, United States

Location

Long Island IVF

Melville, New York, 11747, United States

Location

Related Publications (5)

  • 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.

    PMID: 20971462BACKGROUND

  • 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.

    PMID: 17141767BACKGROUND

  • 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.

    PMID: 19409550BACKGROUND

  • 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.

    PMID: 19939370BACKGROUND

  • 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.

    PMID: 19773223BACKGROUND

MeSH Terms

Conditions

InfertilityAbortion, Spontaneous

Interventions

Prostaglandins D

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

ProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Santiago Munne, PhD

    Reprogenetics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

June 1, 2014

Last Updated

August 21, 2013

Record last verified: 2013-05

Locations

US(4)