Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound

Study Overview
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Brief Summary
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Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.

Official Title
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Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Transvaginal ultrasound-guided embryo transfer
* Procedure: Transabdominal ultrasound-guided embryo transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3 Exclusion Criteria: Submucous or >3 cm intramural fibroids Turner syndrome Black recipients

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transvaginal ultrasound-guided embryo transfer<br>Transvaginal ultrasound-guided transfer of two day-3 embryos | Procedure: Transvaginal ultrasound-guided embryo transfer<br>* Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound<br>* Other names: Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan);|
| Active Comparator: Transabdominal ultrasound-guided embryo transfer<br>Transabdominal ultrasound-guided transfer of two day-3 embryos | Procedure: Transabdominal ultrasound-guided embryo transfer<br>* Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound<br>* Other names: Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Proportion of patients with a positive pregnancy test | At performing the pregnancy test 11 days post-embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Proportion of patients with at least one gestational sac at first pregnancy ultrasound | At first pregnancy ultrasound (3 weeks post-embryo transfer) | 
| Ongoing pregnancy rate | Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer | At 10 weeks post-embryo transfer | 
| Menstruation-like pain | Measured on a three-level scale (none/mild/strong) | At embryo transfer | 
| Discomfort related to vesical distension | Measured on a three-level scale (none/mild/strong) | At embryo transfer | 
| Overall discomfort | Measured on a three-level scale (none/mild/strong) | At embryo transfer | 
| Difficulty using the assigned technique faced by operators | Measured on a three-level scale (easy/moderately difficult/very difficult) | At embryo transfer | 
| Catheterization time |  | At embryo transfer | 
| Conversion to the opposite technique | Proportion of cases in which embryo transfer was performed using the technique of the opposite randomization arm (i.e., proportion of patients randomized to have transabdominal ultrasound-guided transfer in whom transvaginal ultrasound-guided was performed, and the other way around) | At embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography