Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

Study Overview
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Brief Summary
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Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Detailed Description
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Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve pregnancy and live birth. Many reasons have been proposed to explain these results. Among them, the factor Embryo Transfer Procedure gained less of the attention since few papers have been published and most of them had a lot of biases. In order to eliminate possible biases, we wanted to analyze our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches. Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth rate. Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard catheter to pass through the cervix and the orifice, the site of the uterine cavity that the embryo was released, single or double transfer due to blocked embryo in the catheter. In addition for each embryo transfer variables that may influence the pregnancy rates will be collected: age of the woman, number of oocytes harvested, sperm characteristics, fertilization rate, stage and grade of the embryos the day of transfer

Official Title
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Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome

Conditions
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IVF, Pregnancy

Intervention / Treatment
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* Device: embryo transfer catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women undergoing embryo transfer after IVF Exclusion Criteria: Women with known embryo implantation issues

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| soft catheter<br>Patients who underwent embryo transfer with a soft catheter | Device: embryo transfer catheter<br>* undergoing embryo transfer<br>|
| stiff catheter<br>Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass | Device: embryo transfer catheter<br>* undergoing embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with bhCG positive test after embryo transfer | Number of patients bhCG positive up to12 days after embryo transfer | Number of patients bhCG positive up to12 days after embryo transfer | 
| Number of patients with on going clinical pregnancy | Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer | Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer | 
| Number of live births after embryo transfer | Number oflive birth up to9 months after embryo transfer | Number oflive birth up to 9 months after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of fullnes of bladder | Percentage of fullness of the bladder during embryo transfer | At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer | 
| Endometrial thickness | Endometrial thickness prior to embryo transfer | prior to embryo transfer | 
| Uterine axe orientation | Uterine axe orientation during embryo transfer | At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer | 
| Type of embryo transfer catheter | Type of embryo transfer catheter used in the procedure | At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer | 
| Distance from the fundus of the embryo release | Distance from the fundus of the embryo release | At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer | 
| Embryo retained in the catheter | Embryo retained in the catheter | Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer |