InfertilityNCT03317418
Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF
An observational study of Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ATR-FTIR Spectrophotometry
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to Nov 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women attending the fertility clinic at Hillel Yaffe Medical Center
Who may be able to join
- Women undergoing IVF treatments with at least 4 embryos
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Nardin Aslih, MD, nardin_aslih@yahoo.com
About this study
The aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. In addition, the study will explore whether variations detected in the culture medium can be linked to embryo quality and the chances of achieving pregnancy.
- Conditions
- Infertility
- Being tested
- ATR-FTIR Spectrophotometry
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR-FTIR SpectrophotometryOther
Spectrometry imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrometry in embryo culture media
Definition of spectrometry in embryo culture media
Measured: One year
Embryo quality
The spectrometry results will be linked to embryo quality through the linkage between spectrometry results as indicated on Absorbance Graph and embryo quality judged by accepted criteria
Measured: One year
Secondary outcomes (1)
Cycle outcomes
Prediction of pregnancy rates as linked to the spectrometry results of the culture media
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start1 Nov 2017
- Primary completionNov 2023 (estimated)
- Study completionNov 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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom Paz, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317418
- Sponsor's protocol ID
- HYMC-0071-17
- Status last verified
- Jun 2022
- First submitted
- 18 Oct 2017
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pregnancy be Predicted According to ATR-FTIR Spectrophotometry of Incubation Medium of Embryos in IVF
- ClinicalTrials.gov ID
- NCT03317418
- Acronym / sponsor ID
- HYMC-0071-17
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 23 Oct 2017 (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 aim of this study is to examine the variability of culture media composition based on the ATR-FTIR (Attenuated Total Reflectance-Fourier Transform Infrared Spectroscopy) technique on the day of embryo transfer/vitrification. In addition, the study will explore whether variations detected in the culture medium can be linked to embryo quality and the chances of achieving pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women attending the fertility clinic at Hillel Yaffe Medical Center
Key inclusion criteria (1 listed)
- Women undergoing IVF treatments with at least 4 embryos
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| ATR-FTIR SpectrophotometrySpectrometry imaging | Other | – |
Primary outcome
Spectrometry in embryo culture media
Time frame: One year
Definition of spectrometry in embryo culture media
Embryo quality
Time frame: One year
The spectrometry results will be linked to embryo quality through the linkage between spectrometry results as indicated on Absorbance Graph and embryo quality judged by accepted criteria
1 secondary outcome
Cycle outcomes
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
- 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.
Einat Shalom Paz, MD principal investigator
Hillel Yaffe Medical Center
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 Hillel Yaffe Medical Center at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 23 Jun 2022. 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 Israel. 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 Nardin Aslih, MD (972-54-4843909, nardin_aslih@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spectrometry in embryo culture media (time frame: One year). The study lists 2 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 23 Jun 2022.