Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kafrelsheikh University
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- Clinical Pregnancy Rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
360° Catheter Rotation
During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.
Intervention: Embryo Transfer Catheter Withdrawal Technique (Procedure)
No Catheter Rotation
During embryo transfer, the catheter was withdrawn directly without rotational movement.
Intervention: Embryo Transfer Catheter Withdrawal Technique (Procedure)
Outcomes
Primary Outcomes
Clinical Pregnancy Rate
Time Frame: 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 Outcomes
- Chemical Pregnancy Rate(Approximately 14 days after embryo transfer)
Investigators
Ahmed Mohamed Elmoustafa Hussein Mahmoud Abdelkarim
Dr
Kafrelsheikh University