NCT01408433

Brief Summary

This study seeks to compare the pregnancy and delivery rates of patients who undergo a single embryo transfer, when the embryo has been tested and determined to be chromosomally normal, with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of untested embryos.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

August 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

August 1, 2011

Last Update Submit

March 25, 2015

Conditions

Infertility

Keywords

embryo transferin-vitro fertilization (IVF)pre-implantation diagnosis (PGD)infertilitysingle embryo transfertwo embryo transferdouble embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Live birth rate per randomized patient (single embryo transfer vs. 2 embryo transfer)

    Compare live birth rates of patients who have a single embryo transfer of a chromosomally normal embryo with the live birth rates of patients who have two, untested embyros transferred.

    2 years

Secondary Outcomes (3)

  • Twin live birth rate

    2 years

  • Sustained implantation rate (number of viable fetuses beyond the first trimester per embryo transferred)

    2 years

  • Live birth rate per embryo transfer

    2 years

Study Arms (2)

Single Embryo Transfer

OTHER

Patients will have a single, chromosomally normal embryo transferred.

Other: Single Embryo Transfer

Double Embryo Transfer

OTHER

Patients will have two (2) untested embryos transferred.

Other: Double embryo transfer

Interventions

Single Embryo TransferOTHER

single embryo transfer of a chromosomally normal embryo

Also known as: pre-implantation genetic diagnosis (PGD), in-vitro fertilization (IVF)
Single Embryo Transfer
Double embryo transferOTHER

two (2) embryo transfer of untested embryos

Also known as: two embryo transfer, in-vitro fertilization (IVF)
Double Embryo Transfer

Eligibility Criteria

Age18 Years - 43 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Maximum of one (1) prior failed IVF cycle (a failed cycle is any cycle that did not deliver. Pregnancy losses are failed cycles. Ok to participate as a recipient in an egg donor cycle.)
  • Female partner less than 43 years old at time of onset of IVF cycle
  • Maximum prior day 3 follicle stimulation hormone (FSH) level of 12 (in RMA NJ laboratory)
  • Minimum anti-mullerian hormone (AMH)of 1.2 within 1 year
  • Normal uterine cavity demonstrated by saline sonogram, hysterosalpingogram or hysteroscopy within 1 year.
  • Male partner with greater than 100,000 total motile spermatozoa. Donor sperm ok.
  • Body Mass Index (BMI) less than or equal to 30 kg/m2.

You may not qualify if:

  • Diagnosis of chronic anovulation (cycles typically longer than 90 days)
  • Diagnosis of endometrial insufficiency- prior cycle with endometrial thickness less than 6mm, abnormal endometrial echotexture, persistent endometrial fluid.
  • Clinical indication of aneuploidy screening (i.e. history of loss of chromosomally abnormal pregnancies)
  • Clinical indication for PGD for single-gene disorder (i.e. PGD is needed to select against the transfer of embryos affected with a specific condition)
  • Use of testicular aspiration or biopsy procedures to obtain sperm
  • Unevaluated ovarian mass or surgically confirmed stage IV endometriosis
  • Presence of hydrosalpinges which communicate with the endometrial cavity
  • Any contraindication to undergoing in vitro fertilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reproductive Medicine Associated of New Jersey

Morristown, New Jersey, 07960, United States

Location

Reproductive Medicine Associated of Pennsylvania at lehigh Valley

Allentown, Pennsylvania, 18104, United States

Location

Related Publications (1)

  • Forman EJ, Hong KH, Ferry KM, Tao X, Taylor D, Levy B, Treff NR, Scott RT Jr. In vitro fertilization with single euploid blastocyst transfer: a randomized controlled trial. Fertil Steril. 2013 Jul;100(1):100-7.e1. doi: 10.1016/j.fertnstert.2013.02.056. Epub 2013 Mar 30.

    PMID: 23548942DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Single Embryo TransferFertilization in Vitro

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Embryo TransferReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Richard T Scott, MD

    RMA NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 3, 2011

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

December 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(2)