Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Frozen-thawed Embryo Transfers and Fresh Embryo Transfers With Whole Chromosome Analysis Using Next Generation Sequencing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02000349
Recruitment Status : Unknown
Verified November 2015 by Reprogenetics.
Recruitment status was:  Active, not recruiting
First Posted : December 4, 2013
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Reproductive Medicine Lab, LLC
Information provided by (Responsible Party):
Reprogenetics

Brief Summary:
The investigators propose to perform a clinical randomized trial to evaluate the effect of a frozen-thawed embryo transfer and a fresh embryo transfer on pregnancy and implantation rates; with the added benefit of a blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS).

Condition or disease Intervention/treatment Phase
Infertility Other: PGD Phase 2

Detailed Description:
  1. Fresh group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
  2. Frozen group: All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*).

(*) Hatching blastocysts as described by Gardner and Schoolcraft (1999):

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 186 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Screening
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Frozen Embryo Transfer with PGD
All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5 or day 6, embryos will then be vitrified, analyzed by NGS, and will have one or two euploid embryo(s) thawed and transferred on a FET cycle, before noon. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*).
Other: PGD
PGD using Next generation sequencing
Other Names:
  • PGD (Preimplantation Genetic Diagnosis)
  • NGS (Next Generation Sequencing)

Experimental: Fresh Embryo Transfer with PGD
All embryos will be hatched on day 3. Patients will have hatching blastocysts (*) biopsied on day 5, analyzed by NGS, and will have one or two euploid embryo transferred on day 6, in the am. If more than two euploid blastocysts are available the one(s) to be transferred will be selected based on morphology (*). Any morulas developing to hatching blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.
Other: PGD
PGD using Next generation sequencing
Other Names:
  • PGD (Preimplantation Genetic Diagnosis)
  • NGS (Next Generation Sequencing)




Primary Outcome Measures :
  1. Implantation rate [ Time Frame: 8 weeks after replacement ]
    determining whether a frozen or a fresh embryo transfer will improve implantation rate.


Secondary Outcome Measures :
  1. Correlation of Mitochondrial DNA and implantation [ Time Frame: When a fetal heartbeat is detected (8 weeks after implantation) ]
    The second aim of this study is to determine retrospectively if mt DNA content is linked to implantation potential and if that is measurable by NGS. NGS provides the additional advantage that it can measure mitochondrial DNA, which it's content, seems to be inversely correlated with implantation (Fragouli et al 2013, ASRM).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (pre-stimulation):

  • Age up to 42 years

Exclusion Criteria (pre-stimulation):

  • MESA and TESE patients
  • At least one partner carrier of a chromosomal abnormality
  • Egg donor cycle (sperm donor is acceptable)
  • Gender selection cycles
  • Thaw cycles
  • Any patient who cannot have a fresh embryo transfer
  • FSH above 12 or AMH less than 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000349


Locations
Layout table for location information
United States, Oregon
Reproductive Medicine Lab, LLC
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Reprogenetics
Reproductive Medicine Lab, LLC
Investigators
Layout table for investigator information
Study Director: Santiago Munne, PhD Reprogenetics
Publications:
Fragouli E, Spath K, Alfarawati S, Wells D (2013) Quantification of mitochondrial DNA predicts the implantation potential of chromosomally normal embryos. Fertil Steril, in press (ASRM abstract)
Gardner DK and Schoolcraft WB. In vitro culture of human blastocysts. In: Jansen R, Mortimer D. eds. Towards Reproductive Certainty: Fertility and Genetics Beyond 1999. Carnforth, Parthenon Publishin, 1999, 378-88
SART (2011): https://www.sartcorsonline.com/rptCSR_PublicMultYear.aspx?ClinicPKID=0

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Reprogenetics
ClinicalTrials.gov Identifier: NCT02000349    
Other Study ID Numbers: Reprogenetics-3.117
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Reprogenetics:
infertility
next generation sequencing
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility