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Completed

NCT Number: NCT07759765

Embryo Transfer Catheter Rotation Effect on Pregnancy Rate

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.

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Key information

Conditions

ICSI Embryo Transfer

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elshrouk Fertility Hospital

Banhā, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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