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slow recruitment rate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal ultrasound-guided embryo transfer | Experimental | Transvaginal ultrasound-guided transfer of two day-3 embryos |
|
| Transabdominal ultrasound-guided embryo transfer | Active Comparator | Transabdominal ultrasound-guided transfer of two day-3 embryos |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal ultrasound-guided embryo transfer | Procedure | Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy rate | Proportion of patients with a positive pregnancy test | At performing the pregnancy test 11 days post-embryo transfer |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erik E Hauzman, MD, PhD | IVI Madrid | Principal Investigator |
| Juan A Garcia-Velasco, MD, PhD | IVI Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVI Madrid | Madrid | 28023 | Spain |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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|
| Transabdominal ultrasound-guided embryo transfer | Procedure | 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 |
|
|
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 |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |