NCT02712840

Brief Summary

The purpose of this study is to determine whether the chances of becoming pregnant are better when day the single best day 5 embryo (blastocyst) resulting from an in vitro fertilization (IVF) cycle is transferred into the uterus immediately, or after freezing the embryo and transferring it into the uterus in a subsequent cycle, separate from the ovarian stimulation used in the IVF cycle. The investigators hypothesize that in good-prognosis patients, vitrified-warmed elective single embryo transfer will result in higher implantation, clinical and on-going pregnancy and live birth rates than fresh elective single embryo transfer at the blastocyst stage.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2.6 years

First QC Date

September 9, 2015

Last Update Submit

March 26, 2018

Conditions

Infertility

Keywords

Single embryo transferFreeze-allFreshVitrificationClinical PregnancyBlastocyst

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    Ongoing pregnancy is a pregnancy with a positive heart beat beyond 12 weeks of gestation.

    12 weeks of gestation

Secondary Outcomes (7)

  • Implantation rate

    4-5 weeks after date of embryo transfer

  • Clinical pregnancy rate

    4-5 weeks after date of embryo transfer

  • Cumulative implantation rate

    4-5 weeks after date of blastocyst transfer

  • Cumulative clinical pregnancy rate

    4-5 weeks after the date of blastocyst transfer

  • Cumulative ongoing pregnancy rate

    12 weeks of gestation for each pregnancy achieved

  • +2 more secondary outcomes

Study Arms (2)

Freeze-All Protocol

EXPERIMENTAL

Participants freezing all good quality embryos, with subsequent frozen embryo transfer of best quality blastocyst.

Procedure: Freeze-All Protocol

Fresh Protocol

ACTIVE COMPARATOR

Participants receiving fresh embryo transfer of best quality blastocyst and freezing of all good quality supernumerary embryos.

Procedure: Fresh Protocol

Interventions

Freeze-All ProtocolPROCEDURE

All good morphologic quality blastocysts are vitrified on day 5 or 6. The best quality vitrified blastocyst frozen on day 5 will be warmed and transferred in a subsequent cycle.

Freeze-All Protocol
Fresh ProtocolPROCEDURE

Participants receive fresh embryo transfer of best morphologic quality blastocyst on day 5 and vitrification of all good quality supernumerary blastocysts.

Fresh Protocol

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First IVF cycle
  • Normal ovarian reserve parameters (antral follicle count \> 12, follicle stimulating hormone (FSH) \< 10 IU/L, AMH (if measured) \> 15 pmol/L)
  • Infertility cause due to tubal factor, male factor with ejaculated sperm or unexplained
  • or more fresh transfer or cryopreservation-quality blastocysts on day 5 post-oocyte-retrieval
  • GnRH antagonist or long GnRH agonist cycles

You may not qualify if:

  • Evidence of (or evidence for significant risk of) ovarian hyperstimulation syndrome (OHSS) on post-oocyte-retrieval day 5 (in which the standard protocol is not to perform a fresh embryo transfer, but rather to freeze all blastocysts for future frozen embryo transfers).
  • Use of a gonadotropin releasing hormone (GnRH) agonist trigger for ovulation and resulting intensive luteal phase support protocol.
  • Women requiring automatic freeze-all approaches (such as for pre-implantation genetic testing or cryopreservation for fertility preservation).
  • Female infertility causes that may adversely affect implantation, such as severe endometriosis, fibroids, mullerian abnormalities, or prior uterine procedures resulting in a potentially compromised endometrial cavity.
  • In-vitro maturation of oocytes
  • Oocyte donation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5T 2Z5, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ellen Greenblatt, MD CM

    Mount Sinai Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

  • Jason E Elliott, MD, MSc

    Mount Sinai Hospital, University of Toronto

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor; Head - Division of Reproductive Sciences; Clinical Director - Centre for Fertility and Reproductive Health

Study Record Dates

First Submitted

September 9, 2015

First Posted

March 18, 2016

Study Start

September 1, 2015

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CA(1)