Infertility Clinical Trial
Official title:
Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate: A Time-lapse Monitoring Prospective Study
Verified date | March 2023 |
Source | ART Fertility Clinics LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
While numerous types of commercially available human embryo culture media exist for human blastocyst culture, the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood. Culture conditions are very important for the success of the in vitro fertilization (IVF) cycle, many of the factors involved in the process have been extensively studied. However, none of the studies investigated the effect on euploid rate in a sibling oocyte design with preimplantation genetic testing for aneuploidy (PGT-A), which requires culture till day 7. In addition, the clinical outcome (implantation) will be investigated in a frozen cycle regimen. Hence, the study will explore which day of media refreshment will result in higher rate of ploidy and would improve clinical outcomes. Investigators aim at exploring the best practice, that would empower the euploid rate through the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte prospective design.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | December 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Patients with a minimum of 8 - 10 follicles during ovarian stimulation - Patients with a minimum of 8 mature oocytes - PGT-A - ICSI - BMI<35 - Age 18- 40 - Fresh or frozen ejaculatory sperm >10,000 motile sperm - Any Ovarian stimulation - Embryos cultured in Time-lapse system Exclusion Criteria: - PGT-M or PGT-SR - Previous history of embryo arrest - Endometriosis - Hydrosalpinx - History of uterine abnormality or previous uterine surgery - History of previous treatment which may impact the ovarian reserve (adnexal surgery, chemotherapy, radiation…) |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | ART Fertility Clinics | Abu Dhabi | |
United Arab Emirates | Ibrahim Elkhatib | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
ART Fertility Clinics LLC |
United Arab Emirates,
Bavister BD, Poole KA. Duration and temperature of culture medium equilibration affect frequency of blastocyst development. Reprod Biomed Online. 2005 Jan;10(1):124-9. doi: 10.1016/s1472-6483(10)60813-9. — View Citation
Costa-Borges N, Belles M, Meseguer M, Galliano D, Ballesteros A, Calderon G. Blastocyst development in single medium with or without renewal on day 3: a prospective cohort study on sibling donor oocytes in a time-lapse incubator. Fertil Steril. 2016 Mar;105(3):707-713. doi: 10.1016/j.fertnstert.2015.11.038. Epub 2015 Dec 12. — View Citation
Krasnopolskaya KV, Beketova AN, Sesina NI, capital ES, Cyrillichinchenko NK, Badalyan GV, Sudarikova NM, Bocharova TV, Zakharchenko EO. The effect of short-term disturbance of day 3 embryo culture on the development and implantation. Gynecol Endocrinol. 2019;35(sup1):1-4. doi: 10.1080/09513590.2019.1632083. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | blastocyst ploidy | determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development. | 3 days | |
Secondary | cycle ploidy rate | the number of euploid embryos in the group divided by the total number of 2PN | 1 day | |
Secondary | mosaicism frequency | defined as the rate of mosaic errors in aneuploid embryos. This includes full mosaic embryos or aneuploid embryos with 1 or more mosaic chromosome aberration | 1 day | |
Secondary | blastocyst quality at time of biopsy | Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm | 1 day | |
Secondary | blastulation rate | ability of the embryo to form a cavity (=to blastulate) 118hours post ICSI. Number of blastocysts divided by the number of 2PN | 5 days |
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