Metabolic SyndromeNCT01958424
In Vitro Fertilization Outcomes in Metabolic Syndrome
An observational study of Metabolic Syndrome, run by Meir Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes. 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
- Metabolic Syndrome
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Dec 2014
- 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 undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel
Who may be able to join
- women undergoing ivf treatment
Who cannot join
- inflammatory disease
- acute conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Metabolic Syndrome on in Vitro Fertilization Treatment Outcome
The purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.
Read the detailed description
This porpuse of the study is to examine the physiology of CRP during the IVF cycle in and to evaluated the effect of CRP in patient with and without metabolic syndrome on IVF outcomes
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, in vitro fertilization, c reactive protein, over-weight women, ovarian stimulation
- Medical subject headings
- Metabolic Syndrome
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 |
|---|---|---|
| women with metabolic syndrome | women undergoing ivf treatment who have BMI>25 and meet the criteria for metabolic syndrome | |
| women without metabolic syndrome | women undergoing ivf treatment who have BMI>25 and who do not meet the criteria for metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
success or failure of ivf treatment
success or failure of a treatment will be determined by beta-Human chorionic gonadotropin test, number of oocyte retrieved or fertilized and embryos quality.
Measured: within 1 year from intiation of ivf treatment
Secondary outcomes (2)
blood levels of C-reactive protein
Measured: within 1 year from initiation of ivf treatment
follicle liquid levels of C-reactive protein
Measured: within 1 year from initiation of ivf treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amir Waiser, M.D, Principal investigator, "Meir", Medical centere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01958424
- Sponsor's protocol ID
- MMC-16092013-CTIL
- Status last verified
- Oct 2013
- First submitted
- 6 Oct 2013
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Metabolic Syndrome on in Vitro Fertilization Treatment Outcome
- ClinicalTrials.gov ID
- NCT01958424
- Acronym / sponsor ID
- MMC-16092013-CTIL
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, in vitro fertilization, c reactive protein, over-weight women, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Oct 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 purpose of this study is to examine the effect of metabolic syndrome in over-weight women on IVF treatment outcomes.
Detailed description
This porpuse of the study is to examine the physiology of CRP during the IVF cycle in and to evaluated the effect of CRP in patient with and without metabolic syndrome on IVF outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women with metabolic syndrome | – | –women undergoing ivf treatment who have BMI>25 and meet the criteria for metabolic syndrome |
| women without metabolic syndrome | – | –women undergoing ivf treatment who have BMI>25 and who do not meet the criteria for metabolic syndrome |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women undergoing ivf treatment in "Meir" medical center in "Kfar-Saba, Israel
Key inclusion criteria (1 listed)
- women undergoing ivf treatment
Key exclusion criteria (2 listed)
- inflammatory disease
- acute conditions
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
success or failure of ivf treatment
Time frame: within 1 year from intiation of ivf treatment
success or failure of a treatment will be determined by beta-Human chorionic gonadotropin test, number of oocyte retrieved or fertilized and embryos quality.
2 secondary outcomes
blood levels of C-reactive protein
Time frame: within 1 year from initiation of ivf treatment
follicle liquid levels of C-reactive protein
Time frame: within 1 year from initiation of ivf treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- 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.
Amir Waiser, M.D principal investigator
"Meir", Medical centere
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 Metabolic Syndrome, run by Meir 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 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: finished, as of the sponsor's last update on 11 May 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
success or failure of ivf treatment (time frame: within 1 year from intiation of ivf treatment). 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 11 May 2016.