IVFIAFACTNCT04408547
Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome
An observational study of IVF and Pregnancy, run by Iakentro Fertility Centre at 1 site in Greece.
Trial summary
Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- What is being tested?
- embryo transfer catheter
- Type of treatment
- Medical device
- How many people
- 3,512 participants
- Where
- 1 siteGreece
- Study dates
- 3 Jan 2014to 30 Dec 2019
- 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 49 years
- Women only
- No healthy volunteers
- Adult
Study population: Women undergoing embryo transfer after IVF
Who may be able to join
- Women undergoing embryo transfer after IVF
Who cannot join
- Women with known embryo implantation issues
Trial locations and contacts
1 site in 1 country.
About this study
Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.
Read the detailed description
Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve pregnancy and live birth. Many reasons have been proposed to explain these results. Among them, the factor Embryo Transfer Procedure gained less of the attention since few papers have been published and most of them had a lot of biases. In order to eliminate possible biases, we wanted to analyze our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.
Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth rate.
Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard catheter to pass through the cervix and the orifice, the site of the uterine cavity that the embryo was released, single or double transfer due to blocked embryo in the catheter.
In addition for each embryo transfer variables that may influence the pregnancy rates will be collected: age of the woman, number of oocytes harvested, sperm characteristics, fertilization rate, stage and grade of the embryos the day of transfer
- Being tested
- embryo transfer catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo transfer catheterDevice
undergoing embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| soft catheter | Patients who underwent embryo transfer with a soft catheter Receives: Device: embryo transfer catheter | |
| stiff catheter | Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass Receives: Device: embryo transfer catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with bhCG positive test after embryo transfer
Number of patients bhCG positive up to12 days after embryo transfer
Measured: Number of patients bhCG positive up to12 days after embryo transfer
Number of patients with on going clinical pregnancy
Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer
Measured: Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer
Number of live births after embryo transfer
Number oflive birth up to9 months after embryo transfer
Measured: Number oflive birth up to 9 months after embryo transfer
Secondary outcomes (6)
Percentage of fullnes of bladder
Percentage of fullness of the bladder during embryo transfer
Measured: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Endometrial thickness
Endometrial thickness prior to embryo transfer
Measured: prior to embryo transfer
Uterine axe orientation
Uterine axe orientation during embryo transfer
Measured: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Type of embryo transfer catheter
Type of embryo transfer catheter used in the procedure
Measured: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Distance from the fundus of the embryo release
Distance from the fundus of the embryo release
Measured: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Embryo retained in the catheter
Embryo retained in the catheter
Measured: Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start3 Jan 2014
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
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 IVFStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,512 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iakentro Fertility Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannis Prapas, Iakentro Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408547
- Sponsor's protocol ID
- IakentroFC
- Acronym
- IAFACT
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.
PubMed 15178658
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Factors of Embryo Transfer Procedure That Might Affect the Outcome
- ClinicalTrials.gov ID
- NCT04408547
- Acronym / sponsor ID
- IAFACT / IakentroFC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,512 participants (actual)
- Lead sponsor
- Iakentro Fertility CentreUniversity, hospital or other
- Study start
- 3 Jan 2014 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 29 May 2020 (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.
Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.
Detailed description
Most patients undergoing IVF or ICSI reach a blastocyst embryo transfer but less achieve pregnancy and live birth. Many reasons have been proposed to explain these results. Among them, the factor Embryo Transfer Procedure gained less of the attention since few papers have been published and most of them had a lot of biases. In order to eliminate possible biases, we wanted to analyze our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.
Primary outcomes: bhCG positive rate, pregnancy rate, ongoing pregnancy rate, live birth rate.
Secondary outcomes: Full bladder, uterine ax orientation, Endometrial thickness, type of catheter, straightforward advancement of the preloaded catheter, use of a stiffer hard catheter to pass through the cervix and the orifice, the site of the uterine cavity that the embryo was released, single or double transfer due to blocked embryo in the catheter.
In addition for each embryo transfer variables that may influence the pregnancy rates will be collected: age of the woman, number of oocytes harvested, sperm characteristics, fertilization rate, stage and grade of the embryos the day of transfer
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soft catheter | – | Device: embryo transfer catheterPatients who underwent embryo transfer with a soft catheter |
| stiff catheter | – | Device: embryo transfer catheterPatients who underwent embryo transfer with a stiff catheter because soft couldn't pass |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing embryo transfer after IVF
Key inclusion criteria (1 listed)
- Women undergoing embryo transfer after IVF
Key exclusion criteria (1 listed)
- Women with known embryo implantation issues
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 catheterundergoing embryo transfer | Device | soft catheter, stiff catheter |
Primary outcome
Number of patients with bhCG positive test after embryo transfer
Time frame: Number of patients bhCG positive up to12 days after embryo transfer
Number of patients bhCG positive up to12 days after embryo transfer
Number of patients with on going clinical pregnancy
Time frame: Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer
Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer
Number of live births after embryo transfer
Time frame: Number oflive birth up to 9 months after embryo transfer
Number oflive birth up to9 months after embryo transfer
6 secondary outcomes
Percentage of fullnes of bladder
Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Endometrial thickness
Time frame: prior to embryo transfer
Uterine axe orientation
Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Type of embryo transfer catheter
Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Distance from the fundus of the embryo release
Time frame: At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer
Embryo retained in the catheter
Time frame: Number of patients who underwent embryo transfer and the embryo was retained in the catheter at the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo 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 4 Jun 2020.
- Results publication: PubMed 15178658Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.
- 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?
An observational study of IVF and Pregnancy, run by Iakentro Fertility Centre at 1 site in Greece.
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 1 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 4 Jun 2020. 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 Greece. 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?
Number of patients with bhCG positive test after embryo transfer (time frame: Number of patients bhCG positive up to12 days after embryo transfer). The study lists 3 primary outcomes in all. 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 NCT04408547, 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 4 Jun 2020.