ICSINCT07759765
Embryo Transfer Catheter Rotation Effect on Pregnancy Rate
A study testing Embryo Transfer Catheter Withdrawal Technique in people with ICSI and Embryo Transfer, run by Kafrelsheikh University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- ICSI, Embryo Transfer
- What is being tested?
- Embryo Transfer Catheter Withdrawal Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2024to 12 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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
- Being tested
- Embryo Transfer Catheter Withdrawal Technique
- Keywords
- Embryo transfer, Assisted reproductive technique, Catheter rotation, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo Transfer Catheter Withdrawal TechniqueProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 360° Catheter Rotation | Experimental | During embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement. Receives: Procedure: Embryo Transfer Catheter Withdrawal Technique |
| No Catheter Rotation | Active comparator | During embryo transfer, the catheter was withdrawn directly without rotational movement. Receives: Procedure: Embryo Transfer Catheter Withdrawal Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 4-5 weeks after embryo transfer
Secondary outcomes (1)
Chemical Pregnancy Rate
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.
Measured: Approximately 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start12 Jul 2024
- Primary completion1 Mar 2026
- Study completion12 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ICSIStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Elmoustafa Hussein Mahmoud Abdelkarim, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759765
- Sponsor's protocol ID
- embryo catheter rotation
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29758560
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial Comparing Catheter Rotation and no Rotation During Embryo Transfer on Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT07759765
- Acronym / sponsor ID
- embryo catheter rotation
- Conditions
- ICSI, Embryo Transfer
- Keywords
- Embryo transfer, Assisted reproductive technique, Catheter rotation, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 360° Catheter Rotation | Experimental | Procedure: Embryo Transfer Catheter Withdrawal TechniqueDuring embryo transfer, the catheter was withdrawn using a controlled 360° rotational movement. |
| No Catheter Rotation | Active comparator | Procedure: Embryo Transfer Catheter Withdrawal TechniqueDuring embryo transfer, the catheter was withdrawn directly without rotational movement. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embryo Transfer Catheter Withdrawal TechniqueParticipants 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. | Procedure or surgery | 360° Catheter Rotation, No Catheter Rotation |
Primary outcome
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.
1 secondary outcome
Chemical Pregnancy Rate
Time frame: Approximately 14 days after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Results publication: PubMed 29758560Yayla 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo Transfer Catheter Withdrawal Technique in people with ICSI and Embryo Transfer, run by Kafrelsheikh University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy Rate (time frame: Approximately 4-5 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.