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Trial record 5 of 5 for:    IVI-RMA | Infertility, Female

Evaluation of the Impact of Reduced Oxygen Concentration on Live Birth Rate

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ClinicalTrials.gov Identifier: NCT03147872
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Instituto Universitario IVI
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Brief Summary:
Clinical in vitro fertilization relies on successful embryo culture. The primary goal of embryo culture is to attempt to recapitulate the in vivo conditions as much as possible. In the past decade, the majority embryo culture has been performed at 5% oxygen due to the discovery that the oxygen tension in the fallopian tube (where the embryo is located for the first 3 days after fertilization) is 5%. However, relatively recent studies have demonstrated that the oxygen tension in the uterus (where the embryo is located after day 3) is closer to 2%. This study is a randomized controlled trial that will compare pregnancy rates between embryos cultured in 2% versus 5% after day 3 of development.

Condition or disease Intervention/treatment Phase
Infertility Other: 2% Oxygen Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients and care providers will be masked as to which embryo is randomized to each condition. Investigators will be masked until the data are analyzed.
Primary Purpose: Treatment
Official Title: Lo2 Phase II: A Comparison of Live Birth Rates Between Embryos Cultured in 2% vs. 5% After Day 3 of Embryo Culture
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: 5% Oxygen
All patients' embryos will be cultured in 5% oxygen from day 1 through 3 of development. After day 3 of development, patients randomized to this arm will continue to have their embryos cultured at 5% oxygen until they are deemed to be clinically usable or not clinically usable (as per standard protocol).
Experimental: 2% Oxygen
All patients' embryos will be cultured in 5% oxygen from day 1 through 3 of development. After day 3 of development, patients randomized to this arm will have their embryos cultured at 2% oxygen until they are deemed to be clinically usable or not clinically usable (per standard criteria).
Other: 2% Oxygen
2% oxygen concentration in the incubator in which embryos are being cultured after day 3 of development




Primary Outcome Measures :
  1. Live Birth Rate [ Time Frame: through study completion, an average of 1 year ]
    Delivery of a fetus after 20 weeks of gestation (WHO definition)


Secondary Outcome Measures :
  1. Miscarriage Rate [ Time Frame: through study completion, an average of 1 year ]
    Number of pregnancy losses after visualization of a gestational sac and yolk sac on ultrasound

  2. Gestational Age at delivery [ Time Frame: through study completion, an average of 1 year ]
    The number of weeks gestation completed prior to delivery of the fetus

  3. Birthweight at delivery [ Time Frame: through study completion, an average of 1 year ]
    Weight in grams of fetus at time of delivery

  4. Embryo blastulation rate [ Time Frame: through study completion, an average of 1 year ]
    Number of embryos that progress to the blastocyst developmental stage per fertilized ova

  5. Embryo ploidy status [ Time Frame: through study completion, an average of 1 year ]
    The percentage of embryos that are deemed euploidy by preimplantation genetic screening

  6. Embryo morphologic parameters [ Time Frame: through study completion, an average of 1 year ]
    Assignment of morphologic grade of embryos (as per modified Gardner's criteria)

  7. Cumulative live birth rate [ Time Frame: through study completion, an average of 1 year ]
    The number of live births (per definition above) achieved from all embryos derived from the in vitro fertilization cycle involved in the study for a given patient



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Genotypically female (with functioning ovaries)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Anti-mullerian hormone level (AMH) > 1.0 ng/mL
  • Must have at least one surviving embryo on day three of development
  • Male partner with >100,000 total motile spermatozoa per ejaculate (donor sperm acceptable)
  • Body Mass Index < 35

Exclusion Criteria:

  • 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
  • Completion of the protocol requires a single embryo transfer of an embryo as part of the study. Thus, patients pursuing embryo banking cycles will be excluded from the study.
  • Double embryo transfer

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): NCT03147872


Contacts
Contact: Christine Whitehead, BSN 9736562089 cwhitehead@rmanj.com

Locations
United States, New Jersey
Reproductive Medicine Associates of New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V Whitehead, BSN, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Contact: Talia L Metzgar, RN    973-656-2841    clinicalresearchteam@rmanj.com   
Principal Investigator: Scott J Morin, M.D.         
Principal Investigator: Daniel J Kaser, M.D.         
Spain
IVI RMA Madrid Not yet recruiting
Madrid, Spain
Contact: Monica Toribio Paredes    911802900      
Principal Investigator: Juan Garcia Velasco, MD         
IVI RMA Valencia Not yet recruiting
Valencia, Spain
Contact    963050900      
Principal Investigator: Ernesto Bosch, MD, PhD         
United Arab Emirates
IVI Middle East Not yet recruiting
Abu Dhabi, United Arab Emirates, 60202
Contact: Elissavet Kamperi    +971544116930      
Principal Investigator: Human Fatemi, MD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Instituto Universitario IVI
Investigators
Principal Investigator: Scott Morin, MD Reproductive Medicine Associates of New Jersey
Principal Investigator: Daniel J Kaser, MD Reproductive Medicine Associates of New Jersey

Publications:
Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT03147872     History of Changes
Other Study ID Numbers: RMA-2017-02
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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