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Trial record 14 of 415 for:    shaare zedek

Time-Lapse Incubation for Embryo Culture - Morphokinetics and Environmental Stability

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ClinicalTrials.gov Identifier: NCT02657811
Recruitment Status : Unknown
Verified February 2017 by Ruthie Ronn, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : January 18, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Ruthie Ronn, Shaare Zedek Medical Center

Brief Summary:

Embryo culture and selection has been a continuous challenge in evolution since the birth of In Vitro Fertilization (IVF). Traditionally, embryo quality and its presumed suitability for transfer were assessed based on morphologic features. However, the consensus as to the optimal time points for embryo assessment and as to 'preferable' characteristics have been challenging. Alongside this has been the challenge of achieving balance between multiple points of assessment, yet stabilizing the embryo environment for growth. In standard incubation, each new morphological assessment of embryos in culture theoretically creates an additional disruption to culture.

Most recently, time-lapse incubators (TLI) have been introduced as a novel embryo culture system attempting to limit culture disturbances. These incubators have been integrated with digital imaging, allowing for a substantial limitation in embryo handling and environmental disturbances. They have also introduced new morphokinetic parameters to embryo assessment and to optimizing selection of embryos. Thus far, a limited number of studies have examined the clinical outcomes and value of time lapse monitoring systems versus the more ubiquitous incubators (e.g. multichamber) for reproductive outcomes. In particular, the isolated value of morphokinetics in embryo assessment and of this new stable culture environment in TLI are still in question.

The objectives of this study are to prospectively assess and compare fertility outcomes when embryos are cultured in the TLI system versus more traditional bench incubators (BI). We will specifically assess the added value of the closed and isolated TLI compared to BI on reproductive outcomes, as well as the value of morphokinetic grading in IVF.


Condition or disease Intervention/treatment Phase
Infertility Genetic Diseases Device: Miri, Benchtop Multi-room incubator Device: Miri TL, Time-Lapse incubator Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Time-Lapse Incubation for Embryo Culture - The Impact of Morphokinetics and Environmental Stability on Reproductive Outcomes
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : August 2018

Arm Intervention/treatment
Active Comparator: Bench Incubation
These embryos will be randomized to the bench incubator.
Device: Miri, Benchtop Multi-room incubator
Bench Incubation - Morphologic Assessment These embryos will undergo multiple evaluations using light microscopy and traditional morphologic assessment.

Active Comparator: Time Lapse Incubation
These embryos will be randomized to the Time Lapse Incubator.
Device: Miri TL, Time-Lapse incubator
Time Lapse Incubation - Morphologic/Morphokinetic Assessment These embryos will remain in the TLI and undergo both morphologic and morphokinetic evaluation and grading according to a hierarchical multivariable model. They will not be removed from incubation for the duration of culture.

Active Comparator: Time Lapse Incubation - Modified
These embryos will be randomized to the bench incubator.
Device: Miri TL, Time-Lapse incubator
Time Lapse Incubation - Morphologic Assessment These embryos will remain in the TLI and undergo only traditional morphologic assessment according to accepted criteria with no additional imaging. They will also not be removed from incubation for the duration of culture. The time points and evaluated parameters will be identical to those in arm 1 of the study.




Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 12 weeks gestation ]
    The number of women with a viable pregnancy (including gestational sac and fetal heart beat) at 12 weeks gestation divided by the number of women having an embryo transfer.


Secondary Outcome Measures :
  1. Embryo morphology - Number of pronuclei present following fertilization [ Time Frame: Day 1 post-fertilization ]
    Number of pronuclei present in the embryo 1 day following fertilization. Morphologic assessment parameter used to grade embryo quality.

  2. Embryo morphology - Number of cells present [ Time Frame: Day 2 and Day 3 post-fertilization ]
    Number of cells present in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality.

  3. Embryo morphology - % fragmentation [ Time Frame: Day 2 and Day 3 post-fertilization ]
    Percent fragmentation in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality.

  4. Embryo morphology - Presence of multi nucleation [ Time Frame: Day 2 post-fertilization ]
    Presence of multi-nucleation in the embryo on day 2 following fertilization. Morphologic assessment parameter used to grade embryo quality.

  5. Embryo morphology - Symmetry [ Time Frame: Day 2 and Day 3 post-fertilization ]
    Symmetry in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality.

  6. Embryo morphology - Stage of development at day 5 [ Time Frame: Day 5 post-fertilization ]
    Stage of development in the embryo 5 days following fertilization. Characterized as: Early blastocyst, Blastocyst, Expanded, Hatched/Hatching, or other. Morphologic assessment parameter used to grade embryo quality.

  7. Embryo morphology - Inner Cell Mass (ICM) grade [ Time Frame: Day 5 post-fertilization ]
    ICM grade in the embryo 5 days following fertilization. Morphologic assessment parameter used to grade embryo quality.

  8. Embryo morphology - Trophectoderm grade [ Time Frame: Day 5 post-fertilization ]
    Trophectoderm grade in the embryo 5 days following fertilization. Morphologic assessment parameter used to grade embryo quality.

  9. Embryo morphokinetics - Abrupt division [ Time Frame: Day 0 to Day 3 post-fertilization ]
    Presence or absence of abrupt division of the embryo from one to three or more cells: a morphokinetic assessment parameter used to grade embryo quality.

  10. Embryo morphokinetics - Time of cleavage to five-blastomere embryo [ Time Frame: Day 0 to Day 3 post-fertilization ]
    Presence or absence of optimal time range for cleavage to five-blastomere embryo (48.8-56.6 hours): a morphokinetic assessment parameter used to grade embryo quality.

  11. Embryo morphokinetics - Time from two to four-blastomere embryo [ Time Frame: Day 1 to Day 3 post-fertilization ]
    Presence or absence of optimal time duration of division from 2 to 3 cells and subsequent division to 4 cells (0-0.76 hours): a morphokinetic assessment parameter used to grade embryo quality.

  12. Embryo morphokinetics - Time from two to three-blastomere embryo [ Time Frame: Day 1 to Day 3 post-fertilization ]
    Presence or absence of optimal time duration of division from two-cell to three-cell embryo (0-11.9 hours): a morphokinetic assessment parameter used to grade embryo quality.

  13. Oocyte characteristics - Polar body presence [ Time Frame: Oocyte retrieval until fertilization - less than 1 day ]
    Polar body presence of oocyte on day of oocyte retrieval

  14. Biochemical pregnancy rate [ Time Frame: 14 days after embryo transfer ]
    The number of women with a positive β-hCG approximately 14 days after embryo transfer divided by the number of women having an embryo transfer.

  15. Cumulative ongoing pregnancy rate [ Time Frame: One year from oocyte pickup ]
    Cumulative number of women with a viable pregnancy at 12 weeks (where pregnancy was obtained with fresh and vitrified embryos from the same ovarian stimulation cycle) divided by the number of women having undergone an oocyte pickup cycle.

  16. Live birth rate [ Time Frame: One year and forty weeks ]
    The percentage of all Oocyte Pick Up (OPU) cycles that lead to live birth Approximate time frame will be time of one ovarian stimulation cycle plus term pregnancy

  17. Spontaneous abortion rate [ Time Frame: First 20 weeks of gestation ]
    Loss of an embryo or fetus prior to 20 weeks gestation or weighing less than 500 grams.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients requiring assisted reproductive technologies for one or more of the following reasons:

    • Male factor infertility
    • Unexplained infertility
    • Mechanical factor infertility
    • Ovulatory infertility
  • Patients undergoing fertility treatment at Shaare Zedek Medical Centre alone.
  • Patients attempting pregnancy with autologous gametes.
  • Patients receiving embryo transfers according to the Israel Society of Obstetrics and Gynecology guideline on number of embryos for transfer during in vitro fertilization.
  • Patients undergoing their first or second ICSI cycle (cumulative to all other institutions involved in prior treatment) since their previous pregnancy.
  • BMI criteria: >18 and <30 kg/m2

Exclusion Criteria:

  • An infertility diagnosis that includes the following:

    • Severe male factor infertility requiring testicular aspiration, testicular biopsy for sperm retrieval, or less than 1000 sperm per ejaculate.
    • Untreated hydrosalpinx
    • Persistently thin endometrial lining or endometrial factor
    • Severe Endometriosis
    • Low ovarian reserve (≤8 antral follicle count (AFC) follicles measuring 2 to 10 mm in diameter on day 2-4 of menstrual cycle, or day 3 follicle stimulating hormone (FSH) ≥10 milli-International unit (mIU) /mL)
    • High risk for Ovarian Hyperstimulation Syndrome (Estradiol level >13 000 pmol/L or >20 follicles ≥16 mm diameter during controlled ovarian hyper stimulation, ≥20 oocytes collected).
  • Patients obtaining GnRH agonist for final follicular maturation
  • Patients requiring preimplantation genetic diagnosis (PGD)
  • Patients who require freezing of all oocytes or embryos
  • More than 2 previous cycles of IVF since previous pregnancy
  • Current smokers

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): NCT02657811


Contacts
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Contact: Ruth Ronn, M.D. C.M. 972-2-655-5111 RuthRonn@szmc.org.il
Contact: Talia Eldar-Geva, M.D. Ph.D. 972-2-655-5111 gevat@szmc.org.il

Locations
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Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 9103102
Contact: Ruth Ronn, M.D. C.M.    972-2-655-5111    RuthRonn@szmc.org.il   
Contact: Talia Eldar-Geva, M.D. PhD.    972-2-655-5111    gevat@szmc.org.il   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Ruth Ronn, M.D. C.M. Shaare Zedek Medical Center
Principal Investigator: Talia Eldar-Geva, M.D. Ph.D. Shaare Zedek Medical Center

Additional Information:
Publications:

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Responsible Party: Ruthie Ronn, Dr. Ruth Ronn, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02657811     History of Changes
Other Study ID Numbers: 0169-15-SZMC
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Ruthie Ronn, Shaare Zedek Medical Center:
Time-Lapse Imaging
Embryo Culture Techniques
Fertilization in Vitro
Embryology
Assisted Reproductive Techniques
Infertility
Preimplantation diagnosis

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