Fertilization in VitroNCT02971280
Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome
An observational study of Fertilization in Vitro, run by Rambam Health Care Campus.
Trial summary
Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis. The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Fertilization in Vitro
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: IVF patients (women and men)
Who may be able to join
- Age of female patients: <=39
- Age of male patients: 18-50
Who cannot join
- Smoking
- Alcohol/drug abuse
- Long-term/chronic medications
- Severe health/mental problems
- Dental or other transplants
- Fragile X mutations
- Fertility preservation
Trial locations and contacts
No sites are listed yet.
About this study
Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis.
The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.
Read the detailed description
Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients.
Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.
- Conditions
- Fertilization in Vitro
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate ("take-home baby")
IVF cycle resulting in pregnancy that ends in a live birth.
Measured: 9 months from embryo transfer
Secondary outcomes (1)
Clinical pregnancy rate
Gestational sac(s) seen by ultrasound 1 month after embryo transfer.
Measured: 1 month from embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertilization in VitroStudies 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
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Kol MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971280
- Sponsor's protocol ID
- 0008-16-RMB
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be published in scientific journal. Individual researchers will have access to source data anonymously.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome
- ClinicalTrials.gov ID
- NCT02971280
- Acronym / sponsor ID
- 0008-16-RMB
- Conditions
- Fertilization in Vitro
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- First posted
- 22 Nov 2016 (estimated)
- 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.
Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis.
The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.
Detailed description
Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients.
Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- IVF patients (women and men)
Key inclusion criteria (2 listed)
- Age of female patients: <=39
- Age of male patients: 18-50
Key exclusion criteria (7 listed)
- Smoking
- Alcohol/drug abuse
- Long-term/chronic medications
- Severe health/mental problems
- Dental or other transplants
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
Live birth rate ("take-home baby")
Time frame: 9 months from embryo transfer
IVF cycle resulting in pregnancy that ends in a live birth.
1 secondary outcome
Clinical pregnancy rate
Time frame: 1 month from embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: No. Data will be published in scientific journal. Individual researchers will have access to source data anonymously.
Related trials for Fertilization in Vitro
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertilization in Vitro, run by Rambam Health Care Campus.
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 7 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Shahar Kol, MD (97247773232, skol@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate ("take-home baby") (time frame: 9 months from embryo transfer). 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 22 Nov 2016.