NCT01987856

Brief Summary

Single embryo transfer (SET) has been advocated as a means of reducing the risk of multiple pregnancies, but has meant a reduction in pregnancy risk per embryo transfer. Embryo aneuploidy has been cited as the primary reason for the low embryo implantation achieved in human IVF. In the majority of IVF programs embryo selection has mainly been based on the microscopic assessments embryo. Culturing embryos to the blastocyst stage as a selection mechanism has seen an increase in implantation rates, presumably indicating that morphologically normal blastocysts formed by day 5 of culture may have a reduced aneuploidy rate. Morphological normality does, however, not completely preclude aneuploidy, with many transferred and cryopreserved embryo bearing factors that may hold an increased risk for implantation failure and miscarriage. To select the conditions for single blastocyst transfer that will significantly improve reproductive outcomes; increased implantation, reduced pregnancy loss and increased live birth rates.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

November 13, 2013

Last Update Submit

May 25, 2016

Conditions

Pregnancy

Keywords

aCGHchromosomeblastocysttrophectodermvitrificationnatural cyclepregnancylive birth

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    single live birth per blastocyst transfer

    24 months

Secondary Outcomes (2)

  • Pregnancy rate

    24 months

  • Ongoing pregnancy rate

    24 months

Other Outcomes (1)

  • Euploid rate

    24 months

Study Arms (2)

aCGH screen

ACTIVE COMPARATOR

aCGH screen; euploid blastocyst chosen on 23 plus XY chromosome screening plus blastocyst morphology

Procedure: Blastocyst morphology

Blastocyst morphology

PLACEBO COMPARATOR

blastocysts chosen on morphological criteria only; scaled assessment of blastocyst expansion, inner cell mass and trophectoderm morphology

Procedure: Blastocyst morphology

Interventions

Blastocyst morphologyPROCEDURE

microscopic examination only

Blastocyst morphologyaCGH screen

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients less than 40 years of age with a normal ovarian reserve (\>10 antral follicle count), normal BMI (\>18 and \<30) and who have had no more than 3 previous IVF cycles

You may not qualify if:

  • All patients with less than 5 oocytes collected at the time of OPU will be excluded from the study.
  • All patients with \<2 blastocysts with expansion grade 3 on day 5 of culture will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antalya IVF

Antalya, Antalya, 07080, Turkey (Türkiye)

Location

Related Publications (1)

  • Yang Z, Liu J, Collins GS, Salem SA, Liu X, Lyle SS, Peck AC, Sills ES, Salem RD. Selection of single blastocysts for fresh transfer via standard morphology assessment alone and with array CGH for good prognosis IVF patients:results from a randomized pilot study. Molecular Cytogenetics 2012, 5:24 Ly KD, Agarwal A, Nagy ZP. Preimplantation genetic screening: does it help or hinder IVF treatment and what is the role of the embryo? J Assist Reprod Genet 2011; 28:833-849. Forman EJ,Upham KM, Cheng M, Zhao T, Hong KH, Nathan R. Treff NR, Scott Jr. RT. Comprehensive chromosome screening alters traditional morphology-based embryo selection: a prospective study of 100 consecutive cycles of planned fresh euploid blastocyst transfer. Fertil Steril 2013; 100 (3): 718-724.

    BACKGROUND
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific Advisor

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 19, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2016

Study Completion

September 1, 2017

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

TU(1)