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

November 16, 2015 updated by: Reprogenetics
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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):

Study Type

Interventional

Enrollment (Anticipated)

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97210
        • Reproductive Medicine Lab, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 8 weeks after replacement
determining whether a frozen or a fresh embryo transfer will improve implantation rate.
8 weeks after replacement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
When a fetal heartbeat is detected (8 weeks after implantation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reprogenetics

Collaborators

Reproductive Medicine Lab, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

November 26, 2013

First Posted (Estimate)

December 4, 2013

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reprogenetics-3.117

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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