Infertility
Conditions
Keywords
Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography
Brief summary
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.
Interventions
PROCEDURETransvaginal ultrasound-guided embryo transfer
Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound
PROCEDURETransabdominal ultrasound-guided embryo transfer
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
Sponsors
IVI Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | At performing the pregnancy test 11 days post-embryo transfer | Proportion of patients with a positive pregnancy test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | At 10 weeks post-embryo transfer | Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer |
| Menstruation-like pain | At embryo transfer | Measured on a three-level scale (none/mild/strong) |
| Discomfort related to vesical distension | At embryo transfer | Measured on a three-level scale (none/mild/strong) |
| Clinical pregnancy rate | At first pregnancy ultrasound (3 weeks post-embryo transfer) | Proportion of patients with at least one gestational sac at first pregnancy ultrasound |
| Difficulty using the assigned technique faced by operators | At embryo transfer | Measured on a three-level scale (easy/moderately difficult/very difficult) |
| Catheterization time | At embryo transfer | — |
| Conversion to the opposite technique | At embryo transfer | 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) |
| Overall discomfort | At embryo transfer | Measured on a three-level scale (none/mild/strong) |
Countries
Spain
Outcome results
None listed