In Vitro Fertilisation Outcome
Conditions
Keywords
pH, IVF, live birth rate
Brief summary
The culturing human embryo in vitro is a process of myriad contributing elements. From these factors is the pH of embryo culture media, which is crucial for embryo development. The investigators plan to examine three different pH values of the culture media on the live birth rate of in vitro cultured human embryos.
Detailed description
In vitro fertilisation laboratory is the black box in which early human embryo development of infertile couple occurs. This laboratory holds many variables such as incubator type, air quality, brands of culture media, culture temperature and the pH of culture medium. Despite the importance of the culture medium pH, there is no single RCT has examined its effect on live birth rate post in vitro fertilisation. The investigators of this study believe that leaving this crucial element to the wishes of large companies and media designers is unwise. This RCT aims to provide a conclusive answer on pH effect on live birth rate of in vitro cultured human embryos.
Interventions
OTHERTransfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.
OTHERTransfer embryo from pH 7.3±0.02 either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.
OTHERTransfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6
Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6
Sponsors
Egyptian IVF Center
Banon IVF Center Assiut, Egypt
Ibn Sina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Women age of ≥ 18 to ≤ 40 2. BMI of ≤ 35 (After approval of the DMC on 19 Feb 2021 and the IRB thereafter, BMI is changed from ≤31 to ≤35 based on clinician request. DMC). 3. Normal responder (≥ 10 antral follicle count (AFC) during basal ultrasound examination) 4. PCOS 5. Women who have ≥ 1 year of primary or secondary infertility 6. Tubal factor (unilateral, bilateral obstruction or salpingectomy) 7. Normal semen parameters 8. Male factor: oligoasthenozoospermia or obstructive azoospermia 9. Women who are undergoing their first IVF or ICSI cycle or second IVF Cycle with previous successful attempt 10. Women who will undergo only fresh embryo transfer 11. Women who have normal endometrial thickness (\> 7 mm) and echo-pattern at the time of hCG trigger 12. Women who have normal transvaginal ultrasound during the follicular phase (defined as no intra cavity pathology; e.g. submucousal myomas, polyps or septa)
Exclusion criteria
1. Women who had unilateral oophorectomy 2. Women who had uterine pathology or abnormality 3. Women or their husbands who had abnormal karyotyping 4. Women with history of recurrent abortions or repeated implantation failures 5. Women who had uncontrolled diabetes 6. Women with diagnosed or undiagnosed liver or renal disease 7. Women who had a history of severe ovarian hyperstimulation 8. Women who had history of malignancy or borderline pathology 9. Women who will not meet the inclusion criteria 10. Women who will refuse to participate in the study 11. Women with endometriosis 12. Patient undergoing PGS or PGD 13. Severe male factor and non-obstructive azoospermia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live-birth rate | > 20 weeks of gestation | delivery of one or more viable infants \> 20 weeks of gestation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical pregnancy rate | within 7 weeks of gestation | registered positive hCG ≥14 days after egg collection |
| Clinical pregnancy rate | ≥ 7 weeks of gestation | presence of a foetal sac with a foetal heart beat on ultrasound \> 7 weeks of presence of a foetal sac with a foetal heart beat on ultrasound \> 7 weeks of gestation |
| Ongoing pregnancy rate | within 24 weeks of pregnancy | Continued pregnancy after 20 weeks of gestation |
| Miscarriage rate | within 42 weeks of pregnancy | Loss of pregnancy before week 20 of gestation |
| Term Live birth rate | ≥ 37 weeks of gestation | Delivery of one or more viable infants ≥ 37 weeks of gestation |
| Live-birth-implantation rate | within 42 weeks of gestation | Number of viable neonates per number of embryos transferred |
| Cumulative live birth after one fresh and one frozen transfer | within one year from randomization | Registered live birth from one fresh and one frozen cycles |
| Preterm Birth rate | <37 weeks of gestation | Delivery of one or more viable infants \<37 weeks of gestation |
| Very preterm birth rate | <32 weeks of gestation | Delivery of one or more viable infants \<32 weeks of gestation |
| Cryopreservation rate on day 5/6 | 5-7 Days of inseminating the oocytes | Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte |
| Low birth weight babies | 24 hours after delivery | Viable neonate \< 2500 gm within 24 hours of delivery |
| Congenital malformation | within 42 weeks of gestation | delivery of congenitally malformed babies |
| Fertilisation rate | Within 18 hours of inseminating the oocyte | Presence of 2 pronuclei17±1 hr post insemination/ICSI |
| Cleavage rate | Within 72 hours of inseminating the oocytes | registered divided embryo per fertilised oocyte |
| High quality embryo on day 3 | Within 72 hours of inseminating the oocytes | embryo of 7 or more appropriate-size blastomeres with \< 10 fragmentation by volume per Istanbul Consensus |
| Blastocyst formation rate on day 5/6 | Within 5-7 days of inseminating the oocytes | Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte |
| High-quality blastocyst rate on day 5 | 5 Days of inseminating the oocytes | Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5 |
| Embryo utilization rate | 5-7 days post ICSI | Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes |
| Top-quality embryo utilization rate | 5-7 days post ICSI | number of cryopreserved embryos added to the transferred embryos per fertilized oocytes |
| Still birth | 42 weeks after ICSI | delivery of nonviable babies \> 20 weeks of gestation |
Countries
Egypt
Outcome results
None listed