Embryo Transfer Catheter Rotation Effect on Pregnancy Rate

NCT07759765 | Completed

• 1 other identifier: embryo catheter rotation
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

ICSI; Embryo Transfer

Keywords

Embryo transfer, Assisted reproductive technique, Catheter rotation, Pregnancy

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  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 Outcomes (1)

• Chemical Pregnancy Rate

  Approximately 14 days after embryo transfer

Study Arms (2)

360° Catheter Rotation

EXPERIMENTAL

During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement.

Procedure: Embryo Transfer Catheter Withdrawal Technique

No Catheter Rotation

ACTIVE COMPARATOR

During embryo transfer, the catheter was withdrawn directly without rotational movement.

Procedure: Embryo Transfer Catheter Withdrawal Technique

Interventions

Embryo Transfer Catheter Withdrawal Technique PROCEDURE

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.

360° Catheter Rotation; No Catheter Rotation

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Elshrouk Fertility Hospital

Banhā, Egypt

Location

Related Publications (1)

• Yayla Abide C, Ozkaya E, Sanverdi I, Bostanci Ergen E, Kurek Eken M, Devranoglu B, Bilgic BE, Kilicci C, Kayatas Eser S. Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal. Gynecol Obstet Invest. 2018;83(4):397-403. doi: 10.1159/000489493. Epub 2018 May 14.

  PMID: 29758560 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start: July 12, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 12, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)