Embryo DisorderTRANSFERNCT04574310
Does the Air-bubble Location Influence on the Implantation Rate
An observational study of Embryo Disorder, run by IVI Vigo.
Trial summary
The main objective of the study is to evaluate whether there is any association between the location into the uterine cavity, where the air bubbles containing the pre-embryos were placed, and the implantation rate. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Embryo Disorder
- What is being tested?
- Collect retrospectively data on embryo implantation rate
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2013to 25 Oct 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 30 to 50 years
- Women only
- Adult
Study population: IVIVigo patients with a normal uterine anatomy and a single good quality embryo to transfer at blastocyst stage, performed by the same gynaecologist using the "three-drop technique" were included. All transfer were atraumatic, without blood presence, using soft catheter and with controlled ultrasound transfer. The distance between the fundus surface and the tip of catheter, the distance between the fundus and the air bubble, the endometrial thickness and the implantation rate were recorded.
Who may be able to join
- Patients with normal uterine anatomy, who underwent an ultrasound guided embryo transfer.
- BMI< 30kg/m2.
- Ultrasound guided embryo transfer made by the same researcher.
Who cannot join
- Presence of uterine fibroid in the anterior uterine body that make difficult the transfer visualization.
- Asherman Syndrome.
- Adenomyosis that reduces the uterine cavity visibility.
- Difficult transfers where the use of a semi-rigid cannula sheath is needed to entry into the uterine cavity.
- Previous uterine surgery that alters its anatomy.
- Istmocele
About this study
Official title: Evaluation of the Implantation Rate Depending on the Air Bubble Location Through Ultrasound Into the Uterine Cavity in Pre-embryo Transfer
The main objective of the study is to evaluate whether there is any association between the location into the uterine cavity, where the air bubbles containing the pre-embryos were placed, and the implantation rate. Therefore, the images generated during pre-embryos transfer are available in our database and studied retrospectively.
Read the detailed description
The success of a reproductive treatment is determined by three variables: the pre-embryo quality, endometrial receptiveness and pre-embryo transfer. Several previous studies show a lack of agreement concerning the greatest measurement. For instance, some of them refer to the distance between the catheter and the uterine fundus, whereas some others take as a reference the air-bubble where the pre-embryos were placed.
It is for this reason that in the present study, we aim to evaluate the air bubble location ratio into the uterine cavity with reproductive success, taking into account the different variables to reach success. That is, embryo characteristics (quality, development day) endometrium preparation (cycle type, hormone levels on day 5) and even the transfer procedure (type of catheter, blood, difficulty channeling).
It is a study that aims to collect data from January 2013 to october 2019. To this end, the images generated during pre-embryos transfer are analyzed retrospectively. Therefore, it is evaluated the existing differences on implantation rate according to air-bubble placement into uterine cavity during the transfer procedure.
- Conditions
- Embryo Disorder
- Being tested
- Collect retrospectively data on embryo implantation rate
- Keywords
- embryo, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect retrospectively data on embryo implantation rateOther
Collect retrospectively data on embryo implantation rate
| Study group | Role | What they receive |
|---|---|---|
| Frozen embryo transfer (FET) | Collect retrospectively data on embryo implantation rate Receives: Other: Collect retrospectively data on embryo implantation rate | |
| Intracytoplasmic sperm injection (ICSI) | Collect retrospectively data on embryo implantation rate | |
| oocyte donation | Collect retrospectively data on embryo implantation rate Receives: Other: Collect retrospectively data on embryo implantation rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation rate
Analyze Implantation rate in the groups
Measured: Since September 2013 October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start20 Sep 2013
- Primary completion25 Oct 2019
- Study completion25 Oct 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 Embryo DisorderStudies 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
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ekin DR Muñoz, MD, Principal investigator, IVI Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574310
- Sponsor's protocol ID
- 1607-VGO-056-EM
- Acronym
- TRANSFER
- Status last verified
- Oct 2020
- First submitted
- 28 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedman BE, Lathi RB, Henne MB, Fisher SL, Milki AA. The effect of air bubble position after blastocyst transfer on pregnancy rates in IVF cycles. Fertil Steril. 2011 Mar 1;95(3):944-7. doi: 10.1016/j.fertnstert.2010.07.1063.
PubMed 20810105
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implantation Rate Depending on the Air Bubble Location Through Ultrasound Into the Uterine Cavity in Pre-embryo Transfer
- ClinicalTrials.gov ID
- NCT04574310
- Acronym / sponsor ID
- TRANSFER / 1607-VGO-056-EM
- Conditions
- Embryo Disorder
- Keywords
- embryo, pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- IVI VigoUniversity, hospital or other
- Study start
- 20 Sep 2013 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 5 Oct 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.
The main objective of the study is to evaluate whether there is any association between the location into the uterine cavity, where the air bubbles containing the pre-embryos were placed, and the implantation rate. Therefore, the images generated during pre-embryos transfer are available in our database and studied retrospectively.
Detailed description
The success of a reproductive treatment is determined by three variables: the pre-embryo quality, endometrial receptiveness and pre-embryo transfer. Several previous studies show a lack of agreement concerning the greatest measurement. For instance, some of them refer to the distance between the catheter and the uterine fundus, whereas some others take as a reference the air-bubble where the pre-embryos were placed.
It is for this reason that in the present study, we aim to evaluate the air bubble location ratio into the uterine cavity with reproductive success, taking into account the different variables to reach success. That is, embryo characteristics (quality, development day) endometrium preparation (cycle type, hormone levels on day 5) and even the transfer procedure (type of catheter, blood, difficulty channeling).
It is a study that aims to collect data from January 2013 to october 2019. To this end, the images generated during pre-embryos transfer are analyzed retrospectively. Therefore, it is evaluated the existing differences on implantation rate according to air-bubble placement into uterine cavity during the transfer procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Frozen embryo transfer (FET) | – | Other: Collect retrospectively data on embryo implantation rateCollect retrospectively data on embryo implantation rate |
| Intracytoplasmic sperm injection (ICSI) | – | –Collect retrospectively data on embryo implantation rate |
| oocyte donation | – | Other: Collect retrospectively data on embryo implantation rateCollect retrospectively data on embryo implantation rate |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- IVIVigo patients with a normal uterine anatomy and a single good quality embryo to transfer at blastocyst stage, performed by the same gynaecologist using the "three-drop technique" were included. All transfer were atraumatic, without blood presence, using soft catheter and with controlled ultrasound transfer. The distance between the fundus surface and the tip of catheter, the distance between the fundus and the air bubble, the endometrial thickness and the implantation rate were recorded.
Key inclusion criteria (3 listed)
- Patients with normal uterine anatomy, who underwent an ultrasound guided embryo transfer.
- BMI< 30kg/m2.
- Ultrasound guided embryo transfer made by the same researcher.
Key exclusion criteria (6 listed)
- Presence of uterine fibroid in the anterior uterine body that make difficult the transfer visualization.
- Asherman Syndrome.
- Adenomyosis that reduces the uterine cavity visibility.
- Difficult transfers where the use of a semi-rigid cannula sheath is needed to entry into the uterine cavity.
- Previous uterine surgery that alters its anatomy.
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 |
|---|---|---|
| Collect retrospectively data on embryo implantation rateCollect retrospectively data on embryo implantation rate | Other | Frozen embryo transfer (FET), oocyte donation |
Primary outcome
Implantation rate
Time frame: Since September 2013 October 2019
Analyze Implantation rate in the groups
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 6 Oct 2020.
- Background: PubMed 20810105Friedman BE, Lathi RB, Henne MB, Fisher SL, Milki AA. The effect of air bubble position after blastocyst transfer on pregnancy rates in IVF cycles. Fertil Steril. 2011 Mar 1;95(3):944-7. doi: 10.1016/j.fertnstert.2010.07.1063.
- 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.
Ekin DR Muñoz, MD principal investigator
IVI Vigo
Questions about this trial
What is this clinical trial studying?
An observational study of Embryo Disorder, run by IVI Vigo.
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 6 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 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Implantation rate (time frame: Since September 2013 October 2019). 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 NCT04574310, 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 6 Oct 2020.