Incubator Temperature for Culturing Human Embryos

Study Overview
=================
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).

Official Title
-----------------
Incubator Temperature for Culturing Human Embryos

Conditions
-----------------
Embryo Culture

Intervention / Treatment
-----------------
* Other: Incubator Temp set to 36.5 degree
* Other: Incubator Temp 37 degree


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 33 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Incubator Temp 37 degree<br>We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm. | Other: Incubator Temp 37 degree<br>* We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.<br>|
| Experimental: Incubator Temp set to 36.5 degree<br>We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group. | Other: Incubator Temp set to 36.5 degree<br>* We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal heart beat rate | Compare the fetal heart beat rate between the 2 study arms in the first 3 months following Embryo Transfer. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Measure the pregnancy rate between the 2 study arms in the following one month after Embryo Transfer | one month | 
| Top quality embryos Day3 | Measure the top quality embryos day3 between the 2 study arms in the following week after ICSI | one week | 
| blastocyst formation rate | Measure the blastocyst formation rate between the 2 study arms in the following week after ICSI | one week | 
| Top quality blastocyst | Measure the top quality blastocyst rate between the 2 study arms in the following week after ICSI | one week | 
| Implantation rate | Measure the implantation rate between the 2 study arms in the following first month after Embryo Transfer | one month |