InfertilityNCT03756857
Does the Embryo Transfer Technique Affect the Success of in Vitro Fertilization?
A study testing Afterload Transfer and Trial followed by transfer in people with Infertility and Assisted Reproductive Technology, run by Acibadem Kadiköy Hospital at 1 site in Turkey (Türkiye).
Trial summary
Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique Read more about this study
- Who is it for?
- Ages 20 to 37 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Assisted Reproductive Technology, IVF
- What is being tested?
- Afterload Transfer and Trial followed by transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jan 2019to Dec 2021
- 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 37 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient has given written informed consent
- BMI 18-30 kg/m2
- < 2 previous failed IVF trials
- At least two good quality embryos on the day of transfer
Who cannot join
- Congenital uterine anomaly
- Untreated endometrial polyp or fibroid distorting uterine cavity
- Presence of hydrosalpinx 4.2 or more prior IVF trial failure
- 5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Altunizade Hospital, Unit of ART
Istanbul, 34662
Elif Esra Uyar, MD, +902166494444, esra.uyar@acibadem.com
About this study
Official title: Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique
Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique
Read the detailed description
Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes
- Conditions
- Infertility, Assisted Reproductive Technology, IVF
- Being tested
- Afterload Transfer, Trial followed by transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Afterload TransferProcedure or surgery
Embryo transfer is done by using "afterload transfer" method
Trial followed by transferProcedure or surgery
Embryo transfer is done by using "afterload transfer" method
| Study group | Role | What they receive |
|---|---|---|
| Afterload transfer | Experimental | First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician. Receives: Procedure: Afterload Transfer |
| Trial Followed by Transfer | Experimental | First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed Receives: Procedure: Trial followed by transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
the presence of gestational sac on ultrasound
Measured: 5-6 weeks after embryo transfer
Secondary outcomes (1)
implantation rate
the number of gestational sacs divided by the number of embryos transferred
Measured: 3-4 weeks 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 posted28 Nov 2018
- Study start21 Jan 2019
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Prospective, open, randomized, parallel, two-arm trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem Kadiköy Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, deniz usal, Acibadem Kadiköy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03756857
- Sponsor's protocol ID
- AcibademKD
- Status last verified
- Mar 2021
- First submitted
- 27 Nov 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IVF Success Rates Between Different Embryo Transfer Techniques: Afterload Technique and Trial Followed by Transfer Technique
- ClinicalTrials.gov ID
- NCT03756857
- Acronym / sponsor ID
- AcibademKD
- Conditions
- Infertility, Assisted Reproductive Technology, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Acibadem Kadiköy HospitalUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Nov 2018 (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.
Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique
Detailed description
Eligible patients will be informed about the possibility of participating in the clinical trial in the beginning of treatment and on the day ET, a signed consent form will be collected from those recipients who confirmed their participation. These patients will be randomized immediately before the ET procedure by sequentially numbered, opaque, sealed envelopes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, open, randomized, parallel, two-arm trial
| Arm | Type | Receives |
|---|---|---|
| Afterload transfer | Experimental | Procedure: Afterload TransferFirst, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician. |
| Trial Followed by Transfer | Experimental | Procedure: Trial followed by transferFirst a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patient has given written informed consent
- BMI 18-30 kg/m2
- < 2 previous failed IVF trials
- At least two good quality embryos on the day of transfer
Key exclusion criteria (4 listed)
- Congenital uterine anomaly
- Untreated endometrial polyp or fibroid distorting uterine cavity
- Presence of hydrosalpinx 4.2 or more prior IVF trial failure
- 5.Moderate to severe endometriosis 6.Recurrent pregnancy loss history
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 |
|---|---|---|
| Afterload TransferEmbryo transfer is done by using "afterload transfer" method | Procedure or surgery | Afterload transfer |
| Trial followed by transferEmbryo transfer is done by using "afterload transfer" method | Procedure or surgery | Trial Followed by Transfer |
Primary outcome
clinical pregnancy rate
Time frame: 5-6 weeks after embryo transfer
the presence of gestational sac on ultrasound
1 secondary outcome
implantation rate
Time frame: 3-4 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Afterload Transfer and Trial followed by transfer in people with Infertility and Assisted Reproductive Technology, run by Acibadem Kadiköy Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elif Esra UYAR, MD (+902166494444, esra.uyar@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate (time frame: 5-6 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2021.