Infertility Clinical Trial
Official title:
Time-Lapse Incubation for Embryo Culture - The Impact of Morphokinetics and Environmental Stability on Reproductive Outcomes
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.
Status | Recruiting |
Enrollment | 372 |
Est. completion date | August 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Shaare Zedek Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Shaare Zedek Medical Center |
Israel,
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* Note: There are 26 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ongoing pregnancy rate | 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. | 12 weeks gestation | |
Secondary | Embryo morphology - Number of pronuclei present following fertilization | Number of pronuclei present in the embryo 1 day following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 1 post-fertilization | |
Secondary | Embryo morphology - Number of cells present | Number of cells present in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 2 and Day 3 post-fertilization | |
Secondary | Embryo morphology - % fragmentation | Percent fragmentation in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 2 and Day 3 post-fertilization | |
Secondary | Embryo morphology - Presence of multi nucleation | Presence of multi-nucleation in the embryo on day 2 following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 2 post-fertilization | |
Secondary | Embryo morphology - Symmetry | Symmetry in the embryo 2 and 3 days following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 2 and Day 3 post-fertilization | |
Secondary | Embryo morphology - Stage of development at day 5 | 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. | Day 5 post-fertilization | |
Secondary | Embryo morphology - Inner Cell Mass (ICM) grade | ICM grade in the embryo 5 days following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 5 post-fertilization | |
Secondary | Embryo morphology - Trophectoderm grade | Trophectoderm grade in the embryo 5 days following fertilization. Morphologic assessment parameter used to grade embryo quality. | Day 5 post-fertilization | |
Secondary | Embryo morphokinetics - Abrupt division | 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. | Day 0 to Day 3 post-fertilization | |
Secondary | Embryo morphokinetics - Time of cleavage to five-blastomere embryo | 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. | Day 0 to Day 3 post-fertilization | |
Secondary | Embryo morphokinetics - Time from two to four-blastomere embryo | 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. | Day 1 to Day 3 post-fertilization | |
Secondary | Embryo morphokinetics - Time from two to three-blastomere embryo | 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. | Day 1 to Day 3 post-fertilization | |
Secondary | Oocyte characteristics - Polar body presence | Polar body presence of oocyte on day of oocyte retrieval | Oocyte retrieval until fertilization - less than 1 day | |
Secondary | Biochemical pregnancy rate | The number of women with a positive ß-hCG approximately 14 days after embryo transfer divided by the number of women having an embryo transfer. | 14 days after embryo transfer | |
Secondary | Cumulative ongoing pregnancy rate | 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. | One year from oocyte pickup | |
Secondary | Live birth rate | 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 | One year and forty weeks | |
Secondary | Spontaneous abortion rate | Loss of an embryo or fetus prior to 20 weeks gestation or weighing less than 500 grams. | First 20 weeks of gestation |
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