Embryo Culture
Conditions
Brief summary
Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37 degree or slightly lower 36.5 degree and extensively investigate to find which is better to crucially introduce a solid evidence through this RCT.
Detailed description
Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved dramatically. The evolution includes both the ovarian stimulation protocols and the laboratory techniques. Optimization of the laboratory procedures is of great interest to the scientists in the field of IVF. Incubator temperature is one of the most precious variables in IVF labs. When the IVF started, almost all incubator temperatures were set at 37 degrees which mimic in vivo conditions. Some authors speculated that gametes and early embryos might need low temperatures that provide quieter metabolism. another group found increase in pregnancy rate for embryos cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority of embryologists still consider culture at 37 degrees is the back bone for the incubators. The paucity of well designed studies makes it difficult to achieve a satisfactory answer whether lower temperature will improve the pregnancy rate. This encourage us to study the effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional temperature (37 degrees).
Interventions
OTHERIncubator Temp set to 36.5 degree
We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
OTHERIncubator Temp 37 degree
We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
Sponsors
Ibn Sina Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 33 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged ≤ 33 years * BMI ≤ 33 * Normal responder ( ≥ 8 MII ) * Fresh cycle * First attempt (or with previous successful attempt) * Normal or mild oligoasthenoteratozoospermia
Exclusion criteria
* Testicular sperm * \< 8 MIII collected * Difficult transfer cycle * endometriotic patients * Poor Endometrium \< 8mm diameter at OPU
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fetal heart beat rate | 3 months | Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | one month | Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer |
| Top quality embryos Day3 | one week | Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI |
| Top quality blastocyst | one week | Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI |
| Implantation rate | one month | Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer |
| blastocyst formation rate | one week | Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cleavage rate on day 3 | one month | We will measure the rate of embryo cleavage on day3 between the 2 study arms |
Countries
Egypt
Outcome results
None listed