InfertilityNCT05564312
The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles
An observational study of Infertility, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The positions of the air bubble and the tip of catheter will be measured by transabdominal utrasonography among patients who have undergone high-quality frozen blastocyst transfer. The aim of this study is to compare pregnancy rates according to air bubble's final location in endometrial cavity. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Transabdominal ultrasonographic guidance at embryo transfer.
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Observational
- 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 18 to 40 years
- Women only
- Adult
Study population: All patients who have artificial endometrial preparation with high-quality blastocysts between December 2021 and December 2022 will be included.
Who may be able to join
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Who cannot join
- Patients whose treatments were canceled for any reason before the embryo transfer procedure
- Patients who underwent embryo transfer in the cleavage stage
- Presence of low-quality (<2BB) blastocysts
- >15% loss of viability of the embryo during embryo thawing,
- Patients with congenital uterine malformations,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Akdeniz University
Antalya, 07700
Şafak Olgan, MD, +905064068740, safakolgan@gmail.com
Arif C Özsipahi, MD, +905068301073, a.canozsipahi@hotmail.com
About this study
Official title: The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles Using High-Quality Blastocyst Stage Embryos: a Prospective Cohort Study
The positions of the air bubble and the tip of catheter will be measured by transabdominal utrasonography among patients who have undergone high-quality frozen blastocyst transfer. The aim of this study is to compare pregnancy rates according to air bubble's final location in endometrial cavity. It is expected that the ET technique will be improved and live birth rates will increase by determining the optimal position of the embryo in the endometrial cavity during ET in patients who have achieved pregnancy.
Read the detailed description
Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of high-quality embryos is high, possible embryo-induced implantation failure will be minimized. The positions of the air bubble and the catheter in the endometrial cavity in patients with and without pregnancy will be compared.
In patients participating in the study, the transfer catheter will be loaded using a "three drop technique," in which the drop of medium containing the embryo(s) is/are separated from a preceding and a following drop of the medium by an air bubble.
In hormonally prepared frozen embryo cycles, during embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.
If the position of the embryo in the endometrial cavity is determined during ET in patients who have achieved pregnancy, an ET technique can be defined that predicts the optimum for the physician who will perform the transfer. Therefore, an increase in implantation and pregnancy rates can be achieved.
- Conditions
- Infertility
- Being tested
- Transabdominal ultrasonographic guidance at embryo transfer.
- Keywords
- air bubble position, embryo transfer, ultrasonographic guidance
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal ultrasonographic guidance at embryo transfer.Device
During embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| non-pregnant | Negative b-hCG results 9 days after embryo transfer. Receives: Device: Transabdominal ultrasonographic guidance at embryo transfer. | |
| pregnant | Positive b-hCG results 9 days after embryo transfer. Receives: Device: Transabdominal ultrasonographic guidance at embryo transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive β-hCG results
Positive β-hCG results nine days after embryo transfer.
Measured: Nine days after each embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Dec 2021
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Dec 2023 (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.
- More trials run by Akdeniz 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞAFAK OLGAN, Akdeniz University
- Investigators
- ŞAFAK OLGAN, MD, Principal investigator, Akdeniz UniversityARİF C ÖZSİPAHİ, MD, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05564312
- Sponsor's protocol ID
- 49829699
- Status last verified
- May 2023
- First submitted
- 29 Sep 2022
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Embryo Transfer Technique on Pregnancy Outcomes in HRT-FET Cycles Using High-Quality Blastocyst Stage Embryos: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05564312
- Acronym / sponsor ID
- 49829699
- Conditions
- Infertility
- Keywords
- air bubble position, embryo transfer, ultrasonographic guidance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Oct 2022 (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 positions of the air bubble and the tip of catheter will be measured by transabdominal utrasonography among patients who have undergone high-quality frozen blastocyst transfer. The aim of this study is to compare pregnancy rates according to air bubble's final location in endometrial cavity. It is expected that the ET technique will be improved and live birth rates will increase by determining the optimal position of the embryo in the endometrial cavity during ET in patients who have achieved pregnancy.
Detailed description
Only patients who have high-quality blastocyst stage embryos will be included in the study. Since the implantation potential of high-quality embryos is high, possible embryo-induced implantation failure will be minimized. The positions of the air bubble and the catheter in the endometrial cavity in patients with and without pregnancy will be compared.
In patients participating in the study, the transfer catheter will be loaded using a "three drop technique," in which the drop of medium containing the embryo(s) is/are separated from a preceding and a following drop of the medium by an air bubble.
In hormonally prepared frozen embryo cycles, during embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography.
If the position of the embryo in the endometrial cavity is determined during ET in patients who have achieved pregnancy, an ET technique can be defined that predicts the optimum for the physician who will perform the transfer. Therefore, an increase in implantation and pregnancy rates can be achieved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-pregnant | – | Device: Transabdominal ultrasonographic guidance at embryo transfer.Negative b-hCG results 9 days after embryo transfer. |
| pregnant | – | Device: Transabdominal ultrasonographic guidance at embryo transfer.Positive b-hCG results 9 days after embryo transfer. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- All patients who have artificial endometrial preparation with high-quality blastocysts between December 2021 and December 2022 will be included.
Key inclusion criteria (3 listed)
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Key exclusion criteria (5 listed)
- Patients whose treatments were canceled for any reason before the embryo transfer procedure
- Patients who underwent embryo transfer in the cleavage stage
- Presence of low-quality (<2BB) blastocysts
- >15% loss of viability of the embryo during embryo thawing,
- Patients with congenital uterine malformations,
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 |
|---|---|---|
| Transabdominal ultrasonographic guidance at embryo transfer.During embryo transfer in each patient, endometrial thickness, uterine cavity dimensions, distance of transfer catheter to the fundus, distance of released air bubble to the fundus, and distance of air bubble to side walls will be systematically measured and recorded under the guidance of transabdominal ultrasonography. | Device | non-pregnant, pregnant |
Primary outcome
Positive β-hCG results
Time frame: Nine days after each embryo transfer
Positive β-hCG results nine days 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 May 2023.
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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.
ŞAFAK OLGAN, MD principal investigator
Akdeniz University
ARİF C ÖZSİPAHİ, MD study chair
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Akdeniz University 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 3 inclusion and 5 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 May 2023. 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 ŞAFAK OLGAN, MD (00905064068740, safakolgan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive β-hCG results (time frame: Nine days after each 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 May 2023.