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Evaluation of the Impact of Reduced Oxygen Concentration on Embryonic Development (LO2)

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ClinicalTrials.gov Identifier: NCT02919384
Recruitment Status : Completed
First Posted : September 29, 2016
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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).

Condition or disease Intervention/treatment Phase
Infertility Other: 2% oxygen concentration in the incubator Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Impact of Reduced Oxygen Concentration on Embryonic Development
Actual Study Start Date : October 6, 2016
Actual Primary Completion Date : February 10, 2017
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: 2% oxygen concentration in the incubator
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
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.

No Intervention: Control
Embryos in this arm will be cultured at 5% oxygen (current standard of care) from day 3 until blastocyst developmental assessment.



Primary Outcome Measures :
  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) [ Time Frame: 6 days of embryonic development in the laboratory ]
    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.


Secondary Outcome Measures :
  1. Clinical Pregnancy rate [ Time Frame: 2 months ]
    After embryos are cryopreserved, embryos with the proper number of chromosomes (so called euploid embryos) will be available for transfer to the uterus (as is standard protocol in our center). Clinical pregnancy rate will be defined by the presence of a gestational sac on ultrasound in the embryo transfer cycle.


Other Outcome Measures:
  1. Live birth rate [ Time Frame: 10 months ]
    Delivery of an alive baby will be the criteria for live birth rate assessment



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. Use of oocyte donation
  3. Use of gestational carrier
  4. Use of sperm obtained via surgical procedure
  5. Presence of hydrosalpinges that communicate with endometrial cavity
  6. Single gene disorders, chromosomal translocations or any other disorders requiring more detailed embryo genetic analysis
  7. Couples seeking gender selection for family balancing

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): NCT02919384


Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
Principal Investigator: Scott J Morin, MD Reproductive Medicine Associates of New Jersey

Additional Information:
Publications:
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT02919384     History of Changes
Other Study ID Numbers: Protocol RMA-2016-02
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Reproductive Medicine Associates of New Jersey:
Embryonic development
blastocyst stage

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female