InfertilityNCT05701072
Development of a Screening Tool for Difficult Embryo Transfers
An observational study of Infertility, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
Trial summary
This study aims to investigate the accuracy of a proposed screening tool in identifying difficult embryo transfers (ETs) without doing a mock ET. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Oocyte Pick Up and Embryo Transfer
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 6 Mar 2023to 30 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All women undergoing an ET in ART Fertility Clinics Abu Dhabi and Dubai.
Who may be able to join
- All women undergoing an ET is eligible.
Who cannot join
- No exclusion criteria, women can participate with multiple ET procedures.
Trial locations and contacts
2 sites in 1 country.
United Arab Emirates2 sites
ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate, 60202
ART Fertility Clinics LLC
Dubai
About this study
This study aims to investigate the accuracy of a proposed screening tool in identifying difficult embryo transfers (ETs) without doing a mock ET.
Read the detailed description
So far there has never been a screening tool to identify difficult ETs without doing a mock ET. This is a prospective, longitudinal study including at least 200 ETs. All women undergo a speculum examination at the time of transvaginal oocyte pick-up (OPU), the screening questionnaire will be filled by the Physician doing the OPU procedure. On the day of real ET, the Physician doing the ET will be blinded for the screening result, and fill a second questionnaire after the ET. Combined with the Embryologist recorded parameters, this second questionnaire will be used to categorize ETs as difficult or normal. Participants will NOT undergo any procedures beyond their routine treatment. Once the targeted number of participants are recruited, the questionnaires will be matched to see the accuracy of the screening questionnaire to identify difficult ETs.
Identification of difficult ETs with a non-invasive, free of cost questionnaire can enable selective mock transfers and facilitate the real ET for patients, who would otherwise be only recognized on the day of real ET, after their embryos have been already thawed for transfer.
- Conditions
- Infertility
- Being tested
- Oocyte Pick Up, Embryo Transfer
- Keywords
- infertility, embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte Pick UpProcedure or surgery
The screening questionnaire will be filled by the Physician doing the OPU. The screening questionnaire will be informed by the participant's history. Cervix will be visualized during routine vaginal cleansing for OPU, and its appearance (size, and deviation) will be recorded in the screening questionnaire after the OPU procedure. Finally, a screenshot of the ultrasound used for OPU, showing the cervix and cervical canal in the sagittal plane will be taken during routine procedure and saved in electronic chart.
Embryo TransferProcedure or surgery
When the participants comes back for ET during her routine treatment, ET will be done in exactly the same way in routine treatment. Participant will not undergo any additional manipulation, intervention, nor the procedure will take longer. The Embryologist assisting the procedure will record the duration of the procedure, from the moment the Physician takes the outer ET catheter to his/her hand until he/she passes the cervix and calls for the inner catheter loaded with the embryo. Up on completion of the ET procedure as routine practice, the Physician will fill a questionnaire about the procedure.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Not described Receives: Procedure: Oocyte Pick Up; Procedure: Embryo Transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of difficult ET
Measured: Approximately 4 months
Percentage of screening questionnaires suggesting a difficult ET
Measured: Approximately 4 months
Accuracy of the screening tool to predict difficult ET
Measured: Approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start6 Mar 2023
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Baris Ata, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701072
- Sponsor's protocol ID
- 2208-ABU-007-BA
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2023
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cirillo F, Patrizio P, Baccini M, Morenghi E, Ronchetti C, Cafaro L, Zannoni E, Baggiani A, Levi-Setti PE. The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome? Hum Reprod. 2020 Feb 29;35(2):275-282. doi: 10.1093/humrep/dez290.
PubMed 32100020Dessolle L, Freour T, Barriere P, Jean M, Ravel C, Darai E, Biau DJ. How soon can I be proficient in embryo transfer? Lessons from the cumulative summation test for learning curve (LC-CUSUM). Hum Reprod. 2010 Feb;25(2):380-6. doi: 10.1093/humrep/dep391. Epub 2009 Nov 18.
PubMed 19923166Lopez MJ, Garcia D, Rodriguez A, Colodron M, Vassena R, Vernaeve V. Individualized embryo transfer training: timing and performance. Hum Reprod. 2014 Jul;29(7):1432-7. doi: 10.1093/humrep/deu080. Epub 2014 Apr 29.
PubMed 24781427Noyes N, Licciardi F, Grifo J, Krey L, Berkeley A. In vitro fertilization outcome relative to embryo transfer difficulty: a novel approach to the forbidding cervix. Fertil Steril. 1999 Aug;72(2):261-5. doi: 10.1016/s0015-0282(99)00235-6.
PubMed 10438992Kably Ambe A, Campos Canas JA, Aguirre Ramos G, Carballo Mondragon E, Carrera Lomas E, Ortiz Reyes H, Kisel Laska R. [Evaluation of two transfer embryo systems performed by six physicians]. Ginecol Obstet Mex. 2011 Apr;79(4):196-9. Spanish.
PubMed 21966806Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614.
PubMed 30468239Ata B, Lawrenz B, Melado L, Del Gallego R, Coughlan C, Ruiz F, Marqueta Marques L, El-Damen A, Elkhatib I, Fatemi HM. The ART-ET screening tool: an easy-to-use non-invasive screening method to predict difficult embryo transfers in advance. Hum Reprod. 2025 Apr 1;40(4):647-653. doi: 10.1093/humrep/deaf002.
PubMed 39938557
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Screening Tool for Difficult Embryo Transfers
- ClinicalTrials.gov ID
- NCT05701072
- Acronym / sponsor ID
- 2208-ABU-007-BA
- Conditions
- Infertility
- Keywords
- infertility, embryo transfer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 27 Jan 2023 (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.
This study aims to investigate the accuracy of a proposed screening tool in identifying difficult embryo transfers (ETs) without doing a mock ET.
Detailed description
So far there has never been a screening tool to identify difficult ETs without doing a mock ET. This is a prospective, longitudinal study including at least 200 ETs. All women undergo a speculum examination at the time of transvaginal oocyte pick-up (OPU), the screening questionnaire will be filled by the Physician doing the OPU procedure. On the day of real ET, the Physician doing the ET will be blinded for the screening result, and fill a second questionnaire after the ET. Combined with the Embryologist recorded parameters, this second questionnaire will be used to categorize ETs as difficult or normal. Participants will NOT undergo any procedures beyond their routine treatment. Once the targeted number of participants are recruited, the questionnaires will be matched to see the accuracy of the screening questionnaire to identify difficult ETs.
Identification of difficult ETs with a non-invasive, free of cost questionnaire can enable selective mock transfers and facilitate the real ET for patients, who would otherwise be only recognized on the day of real ET, after their embryos have been already thawed for transfer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Procedure: Oocyte Pick Up, Procedure: Embryo Transfer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women undergoing an ET in ART Fertility Clinics Abu Dhabi and Dubai.
Key inclusion criteria (1 listed)
- All women undergoing an ET is eligible.
Key exclusion criteria (1 listed)
- No exclusion criteria, women can participate with multiple ET procedures.
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 |
|---|---|---|
| Oocyte Pick UpThe screening questionnaire will be filled by the Physician doing the OPU. The screening questionnaire will be informed by the participant's history. Cervix will be visualized during routine vaginal cleansing for OPU, and its appearance (size, and deviation) will be recorded in the screening questionnaire after the OPU procedure. Finally, a screenshot of the ultrasound used for OPU, showing the cervix and cervical canal in the sagittal plane will be taken during routine procedure and saved in electronic chart. | Procedure or surgery | All participants |
| Embryo TransferWhen the participants comes back for ET during her routine treatment, ET will be done in exactly the same way in routine treatment. Participant will not undergo any additional manipulation, intervention, nor the procedure will take longer. The Embryologist assisting the procedure will record the duration of the procedure, from the moment the Physician takes the outer ET catheter to his/her hand until he/she passes the cervix and calls for the inner catheter loaded with the embryo. Up on completion of the ET procedure as routine practice, the Physician will fill a questionnaire about the procedure. | Procedure or surgery | All participants |
Primary outcome
Prevalence of difficult ET
Time frame: Approximately 4 months
Percentage of screening questionnaires suggesting a difficult ET
Time frame: Approximately 4 months
Accuracy of the screening tool to predict difficult ET
Time frame: Approximately 4 months
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 3 Feb 2025.
- Background: PubMed 32100020Cirillo F, Patrizio P, Baccini M, Morenghi E, Ronchetti C, Cafaro L, Zannoni E, Baggiani A, Levi-Setti PE. The human factor: does the operator performing the embryo transfer significantly impact the cycle outcome? Hum Reprod. 2020 Feb 29;35(2):275-282. doi: 10.1093/humrep/dez290.
- Background: PubMed 19923166Dessolle L, Freour T, Barriere P, Jean M, Ravel C, Darai E, Biau DJ. How soon can I be proficient in embryo transfer? Lessons from the cumulative summation test for learning curve (LC-CUSUM). Hum Reprod. 2010 Feb;25(2):380-6. doi: 10.1093/humrep/dep391. Epub 2009 Nov 18.
- Background: PubMed 24781427Lopez MJ, Garcia D, Rodriguez A, Colodron M, Vassena R, Vernaeve V. Individualized embryo transfer training: timing and performance. Hum Reprod. 2014 Jul;29(7):1432-7. doi: 10.1093/humrep/deu080. Epub 2014 Apr 29.
- Background: PubMed 10438992Noyes N, Licciardi F, Grifo J, Krey L, Berkeley A. In vitro fertilization outcome relative to embryo transfer difficulty: a novel approach to the forbidding cervix. Fertil Steril. 1999 Aug;72(2):261-5. doi: 10.1016/s0015-0282(99)00235-6.
- Background: PubMed 21966806Kably Ambe A, Campos Canas JA, Aguirre Ramos G, Carballo Mondragon E, Carrera Lomas E, Ortiz Reyes H, Kisel Laska R. [Evaluation of two transfer embryo systems performed by six physicians]. Ginecol Obstet Mex. 2011 Apr;79(4):196-9. Spanish.
- Background: PubMed 30468239Wood MA, Kerrigan KL, Burns MK, Glenn TL, Ludwin A, Christianson MS, Bhagavath B, Lindheim SR. Overcoming the Challenging Cervix: Identification and Techniques to Access the Uterine Cavity. Obstet Gynecol Surv. 2018 Nov;73(11):641-649. doi: 10.1097/OGX.0000000000000614.
- Derived from this study: PubMed 39938557Ata B, Lawrenz B, Melado L, Del Gallego R, Coughlan C, Ruiz F, Marqueta Marques L, El-Damen A, Elkhatib I, Fatemi HM. The ART-ET screening tool: an easy-to-use non-invasive screening method to predict difficult embryo transfers in advance. Hum Reprod. 2025 Apr 1;40(4):647-653. doi: 10.1093/humrep/deaf002.
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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.
Barbara Lawrenz, PhD study director
ART Fertility Clinics LLC
2 sites 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 ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Arab Emirates. 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?
Prevalence of difficult ET (time frame: Approximately 4 months). 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 NCT05701072, which also lists 7 linked publications.
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 3 Feb 2025.