Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?

Study Overview
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Brief Summary
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Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Detailed Description
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Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes

Official Title
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Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique

Conditions
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Infertility, Assisted Reproductive Technology, IVF

Intervention / Treatment
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* Procedure: Afterload Transfer
* Procedure: Trial followed by transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has given written informed consent BMI 18-30 kg/m2 < 2 previous failed IVF trials At least two good quality embryos on the day of transfer Exclusion Criteria: Congenital uterine anomaly Untreated endometrial polyp or fibroid distorting uterine cavity Presence of hydrosalpinx 4.2 or more prior IVF trial failure 5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 37 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, open, randomized, parallel, two-arm trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afterload transfer<br>First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician. | Procedure: Afterload Transfer<br>* Embryo transfer is done by using afterload transfer method<br>|
| Experimental: Trial Followed by Transfer<br>First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed | Procedure: Trial followed by transfer<br>* Embryo transfer is done by using afterload transfer method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | the presence of gestational sac on ultrasound | 5-6 weeks after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate | the number of gestational sacs divided by the number of embryos transferred | 3-4 weeks after embryo transfer |