Infertility/SterilityNCT03350009
Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
An observational study of Infertility/Sterility, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Assessment of the quality of follicular fluid and early embryo via chemical markers. 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/Sterility
- How many people
- 220 participants
- Where
- 1 siteIsrael
- Study dates
- 11 Dec 2017to Nov 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients undergoing IVF procedures at Carmel Medical Center
Who may be able to join
- Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form.
- Female patients age 18-45
Who cannot join
- Women with any malignancy
- Patient's request to be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Assessment of the quality of follicular fluid and early embryo via chemical markers.
Read the detailed description
The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed
- Conditions
- Infertility/Sterility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High and low grade embryos | The distribution for the high and low grade embryos is based on common morphological grading criteria. | |
| High and low quality follicles | The distribution for the high and low grade oocytes is based on common morphological grading criteria and on different features of the participants such as age. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Different markers discriminating the studied groups.
High correlation between the studied markers and the currently used morphological assessment of the quality of embryos and oocytes will define the potential of the studied markers as a mean for embryo and quality assessment.
The current study is pioneer in the field of assessment of embryos and follicles and this group of markers have not been studied previously, therefore we prefer not to clarify more details
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start11 Dec 2017
- Primary completionJun 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility/SterilityStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martha Direnfeld, Prof., Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350009
- Sponsor's protocol ID
- CMC-16-0163-CTIL
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2017
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
- ClinicalTrials.gov ID
- NCT03350009
- Acronym / sponsor ID
- CMC-16-0163-CTIL
- Conditions
- Infertility/Sterility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 22 Nov 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.
Assessment of the quality of follicular fluid and early embryo via chemical markers.
Detailed description
The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High and low grade embryos | – | –The distribution for the high and low grade embryos is based on common morphological grading criteria. |
| High and low quality follicles | – | –The distribution for the high and low grade oocytes is based on common morphological grading criteria and on different features of the participants such as age. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients undergoing IVF procedures at Carmel Medical Center
Key inclusion criteria (2 listed)
- Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form.
- Female patients age 18-45
Key exclusion criteria (2 listed)
- Women with any malignancy
- Patient's request to be withdrawn from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Different markers discriminating the studied groups.
Time frame: two years
High correlation between the studied markers and the currently used morphological assessment of the quality of embryos and oocytes will define the potential of the studied markers as a mean for embryo and quality assessment. The current study is pioneer in the field of assessment of embryos and follicles and this group of markers have not been studied previously, therefore we prefer not to clarify more details
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- 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.
Martha Direnfeld, Prof. principal investigator
Carmel 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/Sterility, run by Carmel 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 2 inclusion and 2 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 31 Jan 2019. 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?
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?
Different markers discriminating the studied groups. (time frame: two years). 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 31 Jan 2019.