Embryo Transfer Catheter Rotation Effect on Pregnancy Rate
Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Banhā, Egypt
- Elshrouk Fertility Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 360° Catheter Rotation
During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.
|
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.
|
|
Active Comparator: No Catheter Rotation
During embryo transfer, the catheter was withdrawn directly without rotational movement.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Approximately 4-5 weeks after embryo transfer
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chemical Pregnancy Rate
Time Frame: 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.
|
Approximately 14 days after embryo transfer
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- embryo catheter rotation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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