Oxidative StressNCT03382002
Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex and Outcome in IVF
An observational study of Oxidative Stress, run by Carmel Medical Center at 1 site in Israel.
Trial summary
Medium of cumulus-oocyte complex will be assessed for oxidative status. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- TCL
- How many people
- 322 participants
- Where
- 1 siteIsrael
- Study dates
- 28 Nov 2017to 28 Apr 2020
- 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
- No healthy volunteers
- Adult
Study population: Patients undergoing in vitro fertilization
Who may be able to join
- •Patients undergoing in vitro fertilization treatment
Who cannot join
- •Patients undergoing intracytoplasmic sperm injection
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel medical Center
Haifa
Zofnat Wiener, MD, 97248250335, wiener_zofnat@clalit.org.il
About this study
Official title: Evaluation of Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex (COC( as Measured by the TCL Assay and Clinical and Laboratory Outcome Parameters in IVF
Medium of cumulus-oocyte complex will be assessed for oxidative status.
- Conditions
- Oxidative Stress
- Being tested
- TCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCLDiagnostic test
evaluation of oxidative status
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of parameters of oxidative state with cycle outcome (pregnancy: yes/no)
The oxidative status in the incubation medium of the cumulus-oocyte complex will be assessed looking for an association between oxidative parameters and cycle outcome (pregnancy: yes/no))
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 Dec 2017
- Study start28 Nov 2017
- Primary completion28 Nov 2019 (estimated)
- Study completion28 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zofnat Wiener, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382002
- Sponsor's protocol ID
- CarmelMC
- Status last verified
- Jan 2019
- First submitted
- 29 Nov 2017
- Last updated
- 1 Feb 2019
- 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 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex (COC( as Measured by the TCL Assay and Clinical and Laboratory Outcome Parameters in IVF
- ClinicalTrials.gov ID
- NCT03382002
- Acronym / sponsor ID
- CarmelMC
- Conditions
- Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 28 Nov 2019 (estimated)
- Study completion
- 28 Apr 2020 (estimated)
- First posted
- 22 Dec 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.
Medium of cumulus-oocyte complex will be assessed for oxidative status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients undergoing in vitro fertilization
Key inclusion criteria (1 listed)
- •Patients undergoing in vitro fertilization treatment
Key exclusion criteria (1 listed)
- •Patients undergoing intracytoplasmic sperm injection
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 |
|---|---|---|
| TCLevaluation of oxidative status | Diagnostic test | – |
Primary outcome
Association of parameters of oxidative state with cycle outcome (pregnancy: yes/no)
Time frame: two years
The oxidative status in the incubation medium of the cumulus-oocyte complex will be assessed looking for an association between oxidative parameters and cycle outcome (pregnancy: yes/no))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 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.
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 Oxidative Stress, 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 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 1 Feb 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?
Contact Zofnat Wiener, MD (97248250335, wiener_zofnat@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of parameters of oxidative state with cycle outcome (pregnancy: yes/no) (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 1 Feb 2019.