Embryo Transfer, ICSI
Conditions
Keywords
Embryo transfer, Assisted reproductive technique, Catheter rotation, Pregnancy
Brief summary
The goal of this clinical trial was to determine whether rotating the embryo transfer catheter through 360° during its withdrawal improves pregnancy outcomes in women aged 20-35 years undergoing fresh day-3 embryo transfer as part of assisted reproductive treatment. The main questions it aimed to answer were: Does 360° catheter rotation during withdrawal increase the clinical pregnancy rate, defined as the ultrasound confirmation of an intrauterine gestational sac? Does 360° catheter rotation during withdrawal increase the chemical pregnancy rate, defined by a positive pregnancy test? Researchers compared embryo transfer with 360° catheter rotation during catheter withdrawal with embryo transfer without catheter rotation to determine whether this technique improves pregnancy outcomes. Participants were: Undergoing controlled ovarian stimulation, oocyte retrieval, fertilization, and fresh transfer of two day-3 embryos. Being randomly assigned to either 360° catheter rotation during withdrawal or standard catheter withdrawal without rotation. Undergoing pregnancy testing after embryo transfer. Undergoing an ultrasound examination to confirm clinical pregnancy if the pregnancy test was positive.
Interventions
PROCEDUREEmbryo Transfer Catheter Withdrawal Technique
Participants underwent fresh day-3 embryo transfer. In the experimental arm, the catheter was rotated 360° during withdrawal. In the comparator arm, the catheter was withdrawn without rotation.
Sponsors
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants were blinded to their assigned study group. The clinician performing the embryo transfer was not blinded because the assigned catheter withdrawal technique had to be performed during the procedure.
Intervention model description
Participants were randomly assigned in a 1:1 ratio to two parallel groups. In the intervention group, the embryo transfer catheter was rotated 360° during withdrawal. In the control group, the catheter was withdrawn without rotation. Each participant received only the intervention assigned to her group.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Women aged 20-35 years. Body mass index (BMI) less than 40 kg/m². Undergoing fresh day-3 embryo transfer. First embryo transfer cycle. Transfer of two grade A embryos. Willingness to participate and provision of written informed consent.
Exclusion criteria
* Diabetes mellitus, hypertension, thyroid disorders, or other significant systemic diseases. Male-factor infertility. Endometriosis. Uterine-factor infertility, including uterine fibroids, adenomyosis, uterine septum, cesarean scar niche, or endometrial polyps. Difficult embryo transfer. Poor ovarian response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | Approximately 4-5 weeks after embryo transfer | The proportion of participants with an intrauterine gestational sac confirmed by transvaginal ultrasound after embryo transfer. Clinical pregnancy rate was calculated as the number of participants with a confirmed clinical pregnancy divided by the total number of participants in each study arm, multiplied by 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemical Pregnancy Rate | Approximately 14 days after embryo transfer | The proportion of participants with a positive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test after embryo transfer. Chemical pregnancy rate was calculated as the number of participants with a positive pregnancy test divided by the total number of participants in each study arm, multiplied by 100. |
Countries
Egypt
Outcome results
None listed