InfertilityTEXTUGESTNCT03507322
Ultrasound Study by Texturization as a Predictor of Pregnancy in Oocyte Donation Programs
An observational study of Infertility, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Ultrasound texturization
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 7 Nov 2017to 10 Sep 2018
- 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: Infertile women undergoing IVF/ICSI treatment
Who may be able to join
- Body mass index (BMI) between 18 and 30 kg/m2
- Not taking the contraceptive pill in a previous cycle
- Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
- No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
- Physical gynecological exploration without pathological findings
- Gynecological ultrasound study of the uterus with a normal result
Who cannot join
- Ultrasound studies with technical defects in image acquisition
- Simultaneous participation in other studies
- Previous participation in other study which can affect the results of the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes
This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles
- Conditions
- Infertility
- Being tested
- Ultrasound texturization
- Keywords
- texturization, pregnancy rate, oocyte donation, 2D ultrasound, 3D ultrasound, assisted reproductive technology (ART)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound texturizationOther
Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound texturization | Application of ultrasound texturization (2D/3D ultrasound scanning) Receives: Other: Ultrasound texturization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Detection of gestational sac through ultrasound scanning indicating clinical pregnancy
Measured: Around 5-6 weeks after embryo transfer
Biochemical miscarriage rate
Interruption of pregnancy after a positive result in the beta HCG test
Measured: Up to one month after embryo transfer
Clinical miscarriage rate
Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning
Measured: Up to 20 weeks after embryo transfer
Chemical pregnancy rate
Positive result in beta HCG test indicating pregnancy
Measured: Around 14 days after embryo transfer
beta HCG level
Level of beta HCG in the test performed to detect pregnancy
Measured: Around 14 days 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 posted25 Apr 2018
- Study start7 Nov 2017
- Primary completion10 Sep 2018
- Study completion10 Sep 2018
Why it stopped: Clinic management decided to cancel the study for priority reasons
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507322
- Sponsor's protocol ID
- 1605-SEV-034-IR
- Acronym
- TEXTUGEST
- Status last verified
- Sep 2018
- First submitted
- 10 Nov 2017
- Last updated
- 12 Sep 2018
- 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 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes
- ClinicalTrials.gov ID
- NCT03507322
- Acronym / sponsor ID
- TEXTUGEST / 1605-SEV-034-IR
- Conditions
- Infertility
- Keywords
- texturization, pregnancy rate, oocyte donation, 2D ultrasound, 3D ultrasound, assisted reproductive technology (ART)
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Clinic management decided to cancel the study for priority reasons
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 10 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 25 Apr 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.
This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound texturization | – | Other: Ultrasound texturizationApplication of ultrasound texturization (2D/3D ultrasound scanning) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing IVF/ICSI treatment
Key inclusion criteria (6 listed)
- Body mass index (BMI) between 18 and 30 kg/m2
- Not taking the contraceptive pill in a previous cycle
- Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
- No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
- Physical gynecological exploration without pathological findings
Key exclusion criteria (3 listed)
- Ultrasound studies with technical defects in image acquisition
- Simultaneous participation in other studies
- Previous participation in other study which can affect the results of the present study
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 |
|---|---|---|
| Ultrasound texturizationAlong several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning. | Other | Ultrasound texturization |
Primary outcome
Clinical pregnancy rate
Time frame: Around 5-6 weeks after embryo transfer
Detection of gestational sac through ultrasound scanning indicating clinical pregnancy
Biochemical miscarriage rate
Time frame: Up to one month after embryo transfer
Interruption of pregnancy after a positive result in the beta HCG test
Clinical miscarriage rate
Time frame: Up to 20 weeks after embryo transfer
Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning
Chemical pregnancy rate
Time frame: Around 14 days after embryo transfer
Positive result in beta HCG test indicating pregnancy
beta HCG level
Time frame: Around 14 days after embryo transfer
Level of beta HCG in the test performed to detect pregnancy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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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 Infertility, run by Vida Recoletas Sevilla at 1 site in Spain.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 12 Sep 2018. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Clinical pregnancy rate (time frame: Around 5-6 weeks after embryo transfer). The study lists 5 primary outcomes in all. 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 12 Sep 2018.