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| Name | Class |
|---|---|
| Egyptian IVF Center | OTHER |
| Banon IVF Center Assiut, Egypt | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transfer embryos from 7.20±0.02 pH | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.2±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
|
| Transfer embryos from 7.3±0.02 pH | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.3±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
|
| Transfer embryo from 7.4±0.02 | Experimental | In this arm, the intervention is to culture the inseminated oocytes in vitro in a pH of 7.4±0.02 from day 0 to 5/6 post IVF/ICSI. Then according to the result of the randomization, women will receive their embryos that will be cultured in this pH on either Day 3 or Day 5/6 post IVF/ICSI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6 | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| live-birth rate | delivery of one or more viable infants > 20 weeks of gestation | > 20 weeks of gestation |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy rate | registered positive hCG ≥14 days after egg collection | within 7 weeks of gestation |
| Clinical pregnancy rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Fawzy | Ibnsina Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qena Fertility Center | Qina | Qena Governorate | 123456 | Egypt | ||
| Royal Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32024790 | Derived | Fawzy M, Emad M, Wilkinson J, Mansour R, Mahran A, Fetih A, Abdelrahman M, AbdelGhafar H. Triple-arm trial of pH (Tri-pH) effect on live birth after ICSI in Egyptian IVF facilities: protocol of a randomised controlled trial. BMJ Open. 2020 Feb 4;10(2):e034194. doi: 10.1136/bmjopen-2019-034194. |
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| Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6 | Other | 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. |
|
| Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6 | Other | 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 |
|
| ≥ 7 weeks of gestation |
| Ongoing pregnancy rate | Continued pregnancy after 20 weeks of gestation | within 24 weeks of pregnancy |
| Miscarriage rate | Loss of pregnancy before week 20 of gestation | within 42 weeks of pregnancy |
| Term Live birth rate | Delivery of one or more viable infants ≥ 37 weeks of gestation | ≥ 37 weeks of gestation |
| Live-birth-implantation rate | Number of viable neonates per number of embryos transferred | within 42 weeks of gestation |
| Cumulative live birth after one fresh and one frozen transfer | Registered live birth from one fresh and one frozen cycles | within one year from randomization |
| Preterm Birth rate | Delivery of one or more viable infants <37 weeks of gestation | <37 weeks of gestation |
| Very preterm birth rate | Delivery of one or more viable infants <32 weeks of gestation | <32 weeks of gestation |
| Still birth | delivery of nonviable babies > 20 weeks of gestation | 42 weeks after ICSI |
| Low birth weight babies | Viable neonate < 2500 gm within 24 hours of delivery | 24 hours after delivery |
| Congenital malformation | delivery of congenitally malformed babies | within 42 weeks of gestation |
| Fertilisation rate | Presence of 2 pronuclei17±1 hr post insemination/ICSI | Within 18 hours of inseminating the oocyte |
| Cleavage rate | registered divided embryo per fertilised oocyte | Within 72 hours of inseminating the oocytes |
| High quality embryo on day 3 | embryo of 7 or more appropriate-size blastomeres with < 10 fragmentation by volume per Istanbul Consensus | Within 72 hours of inseminating the oocytes |
| Blastocyst formation rate on day 5/6 | Formed blastocyst of any grade on day 5 or 6 per fertilized oocyte | Within 5-7 days of inseminating the oocytes |
| High-quality blastocyst rate on day 5 | Blastocyst of ≥ 3.1.1.grading per Istanbul Consensus on day 5 | 5 Days of inseminating the oocytes |
| Cryopreservation rate on day 5/6 | Number of cryopreserved blastocyst on day 5 and 6 per fertilized oocyte | 5-7 Days of inseminating the oocytes |
| Embryo utilization rate | Embryo Utilization rate (number of cryopreserved embryos added to the transferred embryos per fertilized oocytes | 5-7 days post ICSI |
| Top-quality embryo utilization rate | number of cryopreserved embryos added to the transferred embryos per fertilized oocytes | 5-7 days post ICSI |
| Al Mansurah |
| 123456 |
| Egypt |
| Banon Assiut | Asyut | Egypt |
| Egyptian IVF-ET Center | Cairo | Egypt |
| Amshaj | Sohag | 12345 | Egypt |
| IbnSina IVF Center | Sohag | Egypt |