All IVF PatientsNCT01945658
The Impact of In-Vitro Fertilization (IVF) ON Vitamin D
An observational study of All IVF Patients, run by Hillel Yaffe Medical Center.
Trial summary
The main objective of this study is to determine what is the vitamin D status in Israeli women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low vitamin D level on IVF -ICSI cycles. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- All IVF Patients
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 2015
- 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 20 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All patients undergo IVF treatments
Who may be able to join
- All women undergoing IVF treatment.
- Consented to participate in the study.
Who cannot join
- Any women undergoing any other treatment than IVF will be excluded.
- Any cancer patient who is undergoing IVF will be excluded from the study.
- Patients who are known to have prolactinomas or Hypo/Hyper thyroidism will be excluded from the study.
About this study
Official title: Evaluate the Influence of Different Levels of Vitamin D on IVF -ICSI Cycles. We Will Evaluate as Well the Influence of Increased Estradiol Level in IVF-ICSI Cycles on Peripheral Vitamin D.
The main objective of this study is to determine what is the vitamin D status in Israeli women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low vitamin D level on IVF -ICSI cycles. We will evaluate as well the influence of increased estradiol level in IVF-ICSI cycles on peripheral vitamin D.
We plan to follow vitamin D in infertile women undergoing IVF treatment for various indications, at baseline, during and after controlled ovarian hyperstimulation. Their levels will be measured at baseline (when they first present for basic investigations at our clinic), during the down-regulation phase of their treatment (if their protocol has a down-regulation phase), at each follow-up visit during stimulation (when they are asked to present for measurement of their estradiol (E2) levels), as well as at the conclusion of their treatment (i.e. the day of their pregnancy test). Along with endocrinology profiles, we will also record all the details of treatment outcomes in terms of embryo quality, implantation and clinical pregnancy rates. We also intend to perform follow-up studies of pregnancy outcomes.
Read the detailed description
All patients who require IVF treatment will be eligible for our study; even those who are already known for Glucose intolerance. Those patients being treated for this condition will not have their treatment affected in any way by our study, other than having one additional blood test on the day that they present for their down-regulation ultrasound. They will not be required to give a greater amount of blood, since vitamin D measurements can be determined from the same blood drawn routinely for estradiol (E2) levels.
Those patients who consent to participate in our study will have vitamin D levels drawn at each visit, but will not be required to present more often than otherwise required by their treating physician. Given that the only intervention is one additional blood sample, we do not foresee any side-effect or risks. Results of these tests will not have any impact on patients' IVF treatment protocols, as the test results will not be disclosed until after their treatment has ended, whether in failure or in pregnancy.
Patients' medical history, results of blood tests and the details of their IVF treatment protocol will be entered into a database, which will then be analyzed using parametric or non-parametric tests when appropriate, as required using SPSS. All blood tests levels will be drawn and analyzed in the McGill Reproductive Center's laboratory using a single immunoassay run. Measuring all samples at the same time reduces the possibility of inter-assay variability, reducing the sensitivity of the study. The sample size of experimental patients (with 10% margins of error and 95% confidence limits) is 66 women for a control group of 200. These numbers are easily achievable with the current activity of the McGill Reproductive Centre.
- Conditions
- All IVF Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate in relation to vitamin D levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionJan 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All IVF PatientsStudies 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945658
- Sponsor's protocol ID
- HYMC 0071-13
- Status last verified
- Aug 2013
- First submitted
- 15 Sep 2013
- Last updated
- 18 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Influence of Different Levels of Vitamin D on IVF -ICSI Cycles. We Will Evaluate as Well the Influence of Increased Estradiol Level in IVF-ICSI Cycles on Peripheral Vitamin D.
- ClinicalTrials.gov ID
- NCT01945658
- Acronym / sponsor ID
- HYMC 0071-13
- Conditions
- All IVF Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Nov 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 18 Sep 2013 (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.
The main objective of this study is to determine what is the vitamin D status in Israeli women undergo ART. We want to evaluate the influence of hyper Vitamin D level and low vitamin D level on IVF -ICSI cycles. We will evaluate as well the influence of increased estradiol level in IVF-ICSI cycles on peripheral vitamin D.
We plan to follow vitamin D in infertile women undergoing IVF treatment for various indications, at baseline, during and after controlled ovarian hyperstimulation. Their levels will be measured at baseline (when they first present for basic investigations at our clinic), during the down-regulation phase of their treatment (if their protocol has a down-regulation phase), at each follow-up visit during stimulation (when they are asked to present for measurement of their estradiol (E2) levels), as well as at the conclusion of their treatment (i.e. the day of their pregnancy test). Along with endocrinology profiles, we will also record all the details of treatment outcomes in terms of embryo quality, implantation and clinical pregnancy rates. We also intend to perform follow-up studies of pregnancy outcomes.
Detailed description
All patients who require IVF treatment will be eligible for our study; even those who are already known for Glucose intolerance. Those patients being treated for this condition will not have their treatment affected in any way by our study, other than having one additional blood test on the day that they present for their down-regulation ultrasound. They will not be required to give a greater amount of blood, since vitamin D measurements can be determined from the same blood drawn routinely for estradiol (E2) levels.
Those patients who consent to participate in our study will have vitamin D levels drawn at each visit, but will not be required to present more often than otherwise required by their treating physician. Given that the only intervention is one additional blood sample, we do not foresee any side-effect or risks. Results of these tests will not have any impact on patients' IVF treatment protocols, as the test results will not be disclosed until after their treatment has ended, whether in failure or in pregnancy.
Patients' medical history, results of blood tests and the details of their IVF treatment protocol will be entered into a database, which will then be analyzed using parametric or non-parametric tests when appropriate, as required using SPSS. All blood tests levels will be drawn and analyzed in the McGill Reproductive Center's laboratory using a single immunoassay run. Measuring all samples at the same time reduces the possibility of inter-assay variability, reducing the sensitivity of the study. The sample size of experimental patients (with 10% margins of error and 95% confidence limits) is 66 women for a control group of 200. These numbers are easily achievable with the current activity of the McGill Reproductive Centre.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All patients undergo IVF treatments
Key inclusion criteria (2 listed)
- All women undergoing IVF treatment.
- Consented to participate in the study.
Key exclusion criteria (3 listed)
- Any women undergoing any other treatment than IVF will be excluded.
- Any cancer patient who is undergoing IVF will be excluded from the study.
- Patients who are known to have prolactinomas or Hypo/Hyper thyroidism will be excluded 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
pregnancy rate in relation to vitamin D levels
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2013.
Related trials for All IVF Patients
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Drospirenone-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol in Poor Ovarian Responders Undergoing Freeze-All IVF/ICSI
Poor Ovarian Reserve, Infertility (IVF Patients)
Not yet recruitingObservational study
Difference Between Progestin Primed Ovarian Stimulation Protocol and Antagonist Protocol
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of All IVF Patients, run by Hillel Yaffe Medical Center.
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 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: status not confirmed, as of the sponsor's last update on 18 Sep 2013. 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?
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?
pregnancy rate in relation to vitamin D levels (time frame: 1 year). 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 18 Sep 2013.