NCT02919384

Brief Summary

During this study, patients will undergo a routine in vitro fertilization cycle as they would otherwise if not participating in the study. After eggs have been fertilized they will be cultured as usual until day 3 of embryo development. On day 3 of development, the embryologist will randomize half of the embryos to be cultured in 2% oxygen concentration and the other half at 5%, which is currently the standard of care. All other embryological care procedures will remain the same. On day 5 or 6 of embryo development, the embryos will be evaluated and each blastocyst stage embryo will be recorded. The primary outcome will be the blastulation rate (or percentage of embryos that reach the blastocyst stage).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

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

September 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

October 6, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

September 27, 2016

Last Update Submit

June 25, 2018

Conditions

Infertility

Keywords

Embryonic developmentblastocyst stage

Outcome Measures

Primary Outcomes (1)

  • Blastulation Rate (number of embryos meeting criteria for biopsy and/cryopreservation divided by number of embryos randomized on day 3 to either the experimental or control arm)

    On day 5 and day 6, all embryos are examined under the microscope to see if they 1) meet developmental criteria for embryo biopsy (for chromosomal evaluation) and cryopreservation (since all embryos in this program are cryopreserved while awaiting results from chromosome assessment), or 2) arrest development in the laboratory.

    6 days of embryonic development in the laboratory

Secondary Outcomes (1)

  • Clinical Pregnancy rate

    2 months

Other Outcomes (1)

  • Live birth rate

    10 months

Study Arms (2)

2% oxygen concentration in the incubator

EXPERIMENTAL

At the time that embryos are changed from "cleavage stage media" to "blastocyst stage media" on day 3 of development, half of a given patient's embryos will randomly be placed in an incubator set at 2% oxygen concentration. The splitting of the embryos will be done under low magnification such that the embryologist will have no ability to bias allocation of embryos to 2% or 5% oxygen based on embryo morphology on day 3. The embryos will remain in this incubator until their developmental assessments on day 5 and 6.

Other: 2% oxygen concentration in the incubator

Control

NO INTERVENTION

Embryos in this arm will be cultured at 5% oxygen (current standard of care) from day 3 until blastocyst developmental assessment.

Interventions

2% oxygen concentration in the incubatorOTHER

At the time that embryos are changed from "cleavage stage media" to "blastocyst stage media" on day 3 of development, half of a given patient's embryos will randomly be placed in an incubator set at 2% oxygen concentration. The splitting of the embryos will be done under low magnification such that the embryologist will have no ability to bias allocation of embryos to 2% or 5% oxygen based on embryo morphology on day 3. The embryos will remain in this incubator until their developmental assessments on day 5 and 6.

2% oxygen concentration in the incubator

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years and seeking IVF with aneuploidy screening, which is our current recommendation regardless of study participation
  • Anti-mullerian hormone level (AMH) \> 1.0 pmol/L (an assessment of ovarian reserve)
  • Must have at least two surviving embryos on day 3 of development
  • Male partner with \>100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
  • Body Mass Index \< 35

You may not qualify if:

  • Diagnosis of endometrial insufficiency, as defined by prior cycle with maximal endometrial thickness \<6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), or persistent endometrial fluid
  • Use of oocyte donation
  • Use of gestational carrier
  • Use of sperm obtained via surgical procedure
  • Presence of hydrosalpinges that communicate with endometrial cavity
  • Single gene disorders, chromosomal translocations or any other disorders requiring more detailed embryo genetic analysis
  • Couples seeking gender selection for family balancing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

Location

Related Publications (4)

  • Fischer B, Bavister BD. Oxygen tension in the oviduct and uterus of rhesus monkeys, hamsters and rabbits. J Reprod Fertil. 1993 Nov;99(2):673-9. doi: 10.1530/jrf.0.0990673.

    PMID: 8107053BACKGROUND

  • Bontekoe S, Mantikou E, van Wely M, Seshadri S, Repping S, Mastenbroek S. Low oxygen concentrations for embryo culture in assisted reproductive technologies. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008950. doi: 10.1002/14651858.CD008950.pub2.

    PMID: 22786519BACKGROUND

  • Gardner DK, Wale PL. Analysis of metabolism to select viable human embryos for transfer. Fertil Steril. 2013 Mar 15;99(4):1062-72. doi: 10.1016/j.fertnstert.2012.12.004. Epub 2013 Jan 8.

    PMID: 23312219BACKGROUND

  • Meintjes M, Chantilis SJ, Douglas JD, Rodriguez AJ, Guerami AR, Bookout DM, Barnett BD, Madden JD. A controlled randomized trial evaluating the effect of lowered incubator oxygen tension on live births in a predominantly blastocyst transfer program. Hum Reprod. 2009 Feb;24(2):300-7. doi: 10.1093/humrep/den368. Epub 2008 Oct 16.

    PMID: 18927130BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Scott J Morin, MD

    Reproductive Medicine Associates of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 29, 2016

Study Start

October 6, 2016

Primary Completion

February 10, 2017

Study Completion

May 1, 2018

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)